Pediatric HDPhase 4NCT04376762
Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
A Phase 4 study testing Fibrinogen and Cryoprecipitate in people with Pediatric HD and Bleeding, run by University of Virginia at 1 site in United States.
Trial summary
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Pediatric HD, Bleeding
- What is being tested?
- Fibrinogen and Cryoprecipitate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to 1 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric (age 24 months or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).
Who cannot join
- gestational age < 33 weeks at birth
- gestational age < 35 weeks on the day of surgery
- emergency surgery
- patient or parent history of coagulopathy/clotting abnormalities
- patient history of thrombophilia
- refusal to participate in the study,
Show all 9Show fewer
- known severe allergic reaction/anaphylaxis to fibrinogen concentrate,
- administration of fibrinogen concentrate or cryoprecipitate in the 24 hours prior to surgery
- baseline fibrinogen level higher than 300 mg/dL (to avoid the risk of increasing the fibrinogen level above the normal upper level of 400 mg/dL)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated.
The investigators' hypothesis is that fibrinogen concentrate will be as effective as cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric cardiac surgery patients.
Read more
Study Design: this will be a single-center, prospective, randomized, active-control study in pediatric (24 months of age or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Informed consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia. Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):
- Cryoprecipitate group (dose: 10 ml/kg; active control group) or
- Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who received FC).
The results of this study will be used for publication as well as the first stage towards a significantly larger randomized multi-center trial (see below).
Based on the results of this pilot study the investigators plan to conduct a large multi-center, randomized active-control non-inferiority trial in the future, comparing the use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac surgery with CPB. Ultimately, the results of this trial are likely to improve the care of pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet high-risk patient population.
Read the detailed description
Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):
- Cryoprecipitate group (dose: 10 ml/kg; active control group) or
- Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who initially received FC).
Data to be obtained:
- Demographic/preoperative data: collected from the medical record
- age in days/months (all patients to be younger than 24 months)
- gender
- weight
- preoperative diagnosis
- surgery type \& date (Norwood, arterial switch, truncus arteriosus, Glenn, Fontan, TAPVR, AV canal, tetralogy of Fallot, etc)
- preoperative standard of care labs PT/aPTT/INR/hgb level/ hematocrit/ platelet count/ fibrinogen level (if exists)/ creatinine
- Intra-operative Data:
- CPB time \& aortic cross clamp time
- use of hypothermic circulatory arrest (ice packs placed on the head)
- was post-CPB ultrafiltration performed?
- Platelet count prior to separation from CPB
- was ATIII administered? (thrombate)
- Transfusion requirements: PRBC/Cell Saver/FFP/PLT/ cryo - to be collected as number of units per each product, not volume. (for PLT - was it pooled PLT or single donor apheresis, if possible)
- was rFVIIa given (factor seven, novoseven). Please pay attention - the fact that rFVIIa was ordered DOES NOT mean that was actually administered as we order factor VII for ALL big cases (to have available in the OR) but not necessarily administer it
- Need for ECMO
- Was the chest left open? (always in ECMO, but open chest does not necessarily mean ECMO)
- Postoperative Data
- admission PT/aPTT/INR/platelet count/ fibrinogen level/ hgb level/HCT level (could be obtained from initial ABG)
- Bleeding (Chest drain/s output)
- Need for additional transfusion (PRBC/cell saver/FFP/platelets/cryoprecipitate). Will need to know, if possible, whether transfused from same unit that was already exposed to in the OR or new unit (= new exposure)
- Factor VIIa administration
- re-exploration? (= starting ECMO in the PICU)
- delayed chest closure? (will answer whether went to PICU with chest open)
- Conditions
- Pediatric HD, Bleeding
- Being tested
- Fibrinogen, Cryoprecipitate
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibrinogenDrug
Also called Fibrinogen Concentrate (Human) Injection [Fibryga]
Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).
CryoprecipitateDrug
Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).
| Study group | Role | What they receive |
|---|---|---|
| Fibrinogen Concentrate | Experimental | Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Receives: Drug: Fibrinogen |
| Cryoprecipitate | Active comparator | . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Receives: Drug: Cryoprecipitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery
comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU
Measured: from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit
Secondary outcomes (15)
Comparison of Post CPB Bleeding (in ml) Between the Study Groups
(intraoperatively = cell saver volume in ml; postoperatively = chest drain output in ml)
Measured: from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU
Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Comparison between the study groups of the number of RBC units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Measured: From immediately after study medication administration through postoperative day 7
Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Comparison between the study groups of the number of platelets units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Measured: From immediately after study medication administration through postoperative day 7
Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Comparison between the study groups of the number of plasma units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Measured: From immediately after study medication administration through postoperative day 7
Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Comparison between the study groups of the number of additional cryoprecipitate units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Measured: From immediately after study medication administration through postoperative day 7
Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade
Comparison between study groups of the number of participants with postoperative surgical chest re-exploration in the ICU/OR for excessive bleeding or cardiac tamponade
Measured: from admission to the ICU until postoperative day 7
Incidence of the Use of Factor VIIa for Bleeding
comparison of percent of patients requiring factor VIIa for bleeding (intraoperatively or postoperatively in the ICU between the study groups
Measured: from separation from CPB until 48 hours after surgery
In-hospital Mortality
comparison of the incidence of in-hospital mortality between the study groups
Measured: from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)
Post Operative Acute Kidney Injury (AKI)
comparison of the incidence of postoperative AKI between study groups. AKI will be assessed based on the Acute Kidney Injury Network (AKIN) classification (stages 0-3, with higher stage reflecting worse outcome)
Measured: from admission to the ICU until postoperative day 7
Postoperative Infection
comparison of the incidence of pneumonia, sternal wound infection, mediastinitis, sepsis between study groups
Measured: rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)
Percent of Patients With Postoperative Neurological Injury
Comparison between study groups of the percent of patients with seizures/stroke that occur after surgery
Measured: from admission to the ICU until POD 7
Intubation Time
comparison of the time to intubation from the completion of surgery until extubation in the ICU between the study groups
Measured: from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier)
Postoperative Thromboembolic Event
comparison of the incidence of DVT/PE/shunt thrombosis between the study groups
Measured: from admission to the ICU until 7 days postoperatively
ICU Length of Stay
comparison of the postoperative time period spent in the ICU
Measured: from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier)
Hospital Length of Stay
comparison between the study groups of the time in the hospital from admission to the ICU postoperatively until discharge from the hospital
Measured: from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start26 Oct 2021
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pediatric HDStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Octapharma
- Responsible party
- Principal investigator, Jacob Raphael, University of Virginia
- Investigators
- Keita Ikeda, MD, Study director, UVA Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376762
- Sponsor's protocol ID
- HSR180028-FC vs Cryo
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2020
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hvas AM, Andreasen JB, Christiansen K, Ravn HB. Ex-vivo response to blood products and haemostatic agents after paediatric cardiac surgery. Blood Coagul Fibrinolysis. 2013 Sep;24(6):587-92. doi: 10.1097/MBC.0b013e32836029d2.
PubMed 23571685Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.
PubMed 24951020Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15.
PubMed 25982134Haas T, Cushing MM, Asmis LM. Comparison of the efficacy of two human fibrinogen concentrates to treat dilutional coagulopathy in vitro. Scand J Clin Lab Invest. 2018 May;78(3):230-235. doi: 10.1080/00365513.2018.1437645. Epub 2018 Feb 15.
PubMed 29446989Ranucci M, Baryshnikova E, Crapelli GB, Rahe-Meyer N, Menicanti L, Frigiola A; Surgical Clinical Outcome REsearch (SCORE) Group. Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery. J Am Heart Assoc. 2015 Jun 2;4(6):e002066. doi: 10.1161/JAHA.115.002066.
PubMed 26037084Fassl J, Lurati Buse G, Filipovic M, Reuthebuch O, Hampl K, Seeberger MD, Bolliger D. Perioperative administration of fibrinogen does not increase adverse cardiac and thromboembolic events after cardiac surgery. Br J Anaesth. 2015 Feb;114(2):225-34. doi: 10.1093/bja/aeu364. Epub 2014 Oct 16.
PubMed 25324348
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT04376762
- Acronym / sponsor ID
- HSR180028-FC vs Cryo
- Conditions
- Pediatric HD, Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Octapharma
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated.
The investigators' hypothesis is that fibrinogen concentrate will be as effective as cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric cardiac surgery patients.
Study Design: this will be a single-center, prospective, randomized, active-control study in pediatric (24 months of age or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Informed consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia. Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):
- Cryoprecipitate group (dose: 10 ml/kg; active control group) or
- Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who received FC).
The results of this study will be used for publication as well as the first stage towards a significantly larger randomized multi-center trial (see below).
Based on the results of this pilot study the investigators plan to conduct a large multi-center, randomized active-control non-inferiority trial in the future, comparing the use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac surgery with CPB. Ultimately, the results of this trial are likely to improve the care of pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet high-risk patient population.
Detailed description
Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):
- Cryoprecipitate group (dose: 10 ml/kg; active control group) or
- Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who initially received FC).
Data to be obtained:
- Demographic/preoperative data: collected from the medical record
- age in days/months (all patients to be younger than 24 months)
- gender
- weight
- preoperative diagnosis
- surgery type \& date (Norwood, arterial switch, truncus arteriosus, Glenn, Fontan, TAPVR, AV canal, tetralogy of Fallot, etc)
- preoperative standard of care labs PT/aPTT/INR/hgb level/ hematocrit/ platelet count/ fibrinogen level (if exists)/ creatinine
- Intra-operative Data:
- CPB time \& aortic cross clamp time
- use of hypothermic circulatory arrest (ice packs placed on the head)
- was post-CPB ultrafiltration performed?
- Platelet count prior to separation from CPB
- was ATIII administered? (thrombate)
- Transfusion requirements: PRBC/Cell Saver/FFP/PLT/ cryo - to be collected as number of units per each product, not volume. (for PLT - was it pooled PLT or single donor apheresis, if possible)
- was rFVIIa given (factor seven, novoseven). Please pay attention - the fact that rFVIIa was ordered DOES NOT mean that was actually administered as we order factor VII for ALL big cases (to have available in the OR) but not necessarily administer it
- Need for ECMO
- Was the chest left open? (always in ECMO, but open chest does not necessarily mean ECMO)
- Postoperative Data
- admission PT/aPTT/INR/platelet count/ fibrinogen level/ hgb level/HCT level (could be obtained from initial ABG)
- Bleeding (Chest drain/s output)
- Need for additional transfusion (PRBC/cell saver/FFP/platelets/cryoprecipitate). Will need to know, if possible, whether transfused from same unit that was already exposed to in the OR or new unit (= new exposure)
- Factor VIIa administration
- re-exploration? (= starting ECMO in the PICU)
- delayed chest closure? (will answer whether went to PICU with chest open)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen Concentrate | Experimental | Drug: FibrinogenFibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| Cryoprecipitate | Active comparator | Drug: Cryoprecipitate. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric (age 24 months or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).
Key exclusion criteria (9 listed)
- gestational age < 33 weeks at birth
- gestational age < 35 weeks on the day of surgery
- emergency surgery
- patient or parent history of coagulopathy/clotting abnormalities
- patient history of thrombophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibrinogenAlso: Fibrinogen Concentrate (Human) Injection [Fibryga]Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). | Drug | Fibrinogen Concentrate |
| CryoprecipitateCryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). | Drug | Cryoprecipitate |
Primary outcome
A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery
Time frame: from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit
comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU
15 secondary outcomes
Comparison of Post CPB Bleeding (in ml) Between the Study Groups
Time frame: from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU
Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Time frame: From immediately after study medication administration through postoperative day 7
Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Time frame: From immediately after study medication administration through postoperative day 7
Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Time frame: From immediately after study medication administration through postoperative day 7
Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
Time frame: From immediately after study medication administration through postoperative day 7
Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade
Time frame: from admission to the ICU until postoperative day 7
Incidence of the Use of Factor VIIa for Bleeding
Time frame: from separation from CPB until 48 hours after surgery
In-hospital Mortality
Time frame: from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)
Post Operative Acute Kidney Injury (AKI)
Time frame: from admission to the ICU until postoperative day 7
Postoperative Infection
Time frame: rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)
Percent of Patients With Postoperative Neurological Injury
Time frame: from admission to the ICU until POD 7
Intubation Time
Time frame: from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier)
Postoperative Thromboembolic Event
Time frame: from admission to the ICU until 7 days postoperatively
ICU Length of Stay
Time frame: from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier)
Hospital Length of Stay
Time frame: from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23571685Hvas AM, Andreasen JB, Christiansen K, Ravn HB. Ex-vivo response to blood products and haemostatic agents after paediatric cardiac surgery. Blood Coagul Fibrinolysis. 2013 Sep;24(6):587-92. doi: 10.1097/MBC.0b013e32836029d2.
- Background: PubMed 24951020Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.
- Background: PubMed 25982134Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15.
- Background: PubMed 29446989Haas T, Cushing MM, Asmis LM. Comparison of the efficacy of two human fibrinogen concentrates to treat dilutional coagulopathy in vitro. Scand J Clin Lab Invest. 2018 May;78(3):230-235. doi: 10.1080/00365513.2018.1437645. Epub 2018 Feb 15.
- Background: PubMed 26037084Ranucci M, Baryshnikova E, Crapelli GB, Rahe-Meyer N, Menicanti L, Frigiola A; Surgical Clinical Outcome REsearch (SCORE) Group. Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery. J Am Heart Assoc. 2015 Jun 2;4(6):e002066. doi: 10.1161/JAHA.115.002066.
- Background: PubMed 25324348Fassl J, Lurati Buse G, Filipovic M, Reuthebuch O, Hampl K, Seeberger MD, Bolliger D. Perioperative administration of fibrinogen does not increase adverse cardiac and thromboembolic events after cardiac surgery. Br J Anaesth. 2015 Feb;114(2):225-34. doi: 10.1093/bja/aeu364. Epub 2014 Oct 16.
- Individual participant dataSharing planned: No
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Chronic Myeloproliferative Disorders, Graft Versus Host Disease
Active, not recruitingPhase 2
Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma
RecruitingPhase 4
Pediatric Hodgkin Lymphoma Treatment Trial With Low Cumulative Doses of Chemotherapy Agents and Reduced Radiation.
Pediatric Hodgkin's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keita Ikeda, MD study director
UVA Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fibrinogen and Cryoprecipitate in people with Pediatric HD and Bleeding, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery (time frame: from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376762, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.