HypofibrinogenemiaPhase 4NCT05711524
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
A Phase 4 study testing Traditional Cryoprecipitate and Pathogen-Reduced Cryoprecipitate in people with Hypofibrinogenemia and Bleeding, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypofibrinogenemia, Bleeding
- What is being tested?
- Traditional Cryoprecipitate and Pathogen-Reduced Cryoprecipitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 3 Oct 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
- Cardiovascular surgery includes the following procedures:
- coronary artery bypass grafting
- valve repair or replacement
- open thoracic aortic and thoracoabdominal aortic surgery
- atrial or ventricular septal defects
- ventricular assist device implantation or revision
- or any combination of the above.
Who cannot join
- Patients who do not receive any cryo product in the OR
- Patients who are not cardiovascular surgery or liver transplant patients
- Cardiac transplantation surgery
- Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month.
- Patients who receive less than 1 pool (5 units) of cryo
- Pediatric patients (less than 18 years of age).
- Patients who received both PR cryo and traditional cryo
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: Pilot Clinical Trial of Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen (INTERCEPT Fibrinogen Complex) in Patients With Bleeding to Expedite Product Availability and Improve Outcomes in Perioperative Bleeding
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided.
Participants will be given one of the two FDA-approved blood products.
Read the detailed description
Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used for fibrinogen replacement in the US, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . A modified version of the product, pathogen reduced (PR) cryo, is now FDA approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. In this quality improvement study, the investigators will compare the effect that readily available, pre-thawed PR cryo has on transfusion practice in cardiovascular and liver transplant patients who receive PR cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all PR cryo. All clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care.
- Conditions
- Hypofibrinogenemia, Bleeding
- Being tested
- Traditional Cryoprecipitate, Pathogen-Reduced Cryoprecipitate
- Keywords
- Cryoprecipitate, Pathogen Reduced Cryoprecipitate
- Medical subject headings
- Afibrinogenemia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional CryoprecipitateBiological
This is the cryoprecipitate already currently being given to patients with a cryo order.
Pathogen-Reduced CryoprecipitateBiological
This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
| Study group | Role | What they receive |
|---|---|---|
| Patients given Traditional Cryo | Active comparator | These are the liver transplant and cardiothoracic (LT and CT) patients that will be given traditional cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month. Receives: Biological: Traditional Cryoprecipitate |
| Patients given PR Cryo | Experimental | These are the liver transplant and cardiothoracic (LT and CT) patients that will be given PR cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month. Receives: Biological: Pathogen-Reduced Cryoprecipitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of RBCs Used Over Admission
RBCs used over admission
Measured: Within the first 30 days after surgery.
Total Number of Platelets Used Over Admission
Plts used over admission
Measured: Within the first 30 days after surgery.
Total Number of Plasma Used Over Admission
All units over admission
Measured: Within the first 30 days after surgery.
Secondary outcomes (26)
Number of Cryo Units Used Perioperatively
All products within 3 days
Measured: 3 days post procedure
Number of RBCs Used Perioperatively
Number of RBC units transfused during perioperative period
Measured: 3 days post procedure
Number of Plasma Used Perioperatively
Measured: 3 days post procedure
Number of Platelets Used Perioperatively
Number of platelet units transfused during perioperative period
Measured: 3 days post procedure
Time From Operating Room (OR) Start Time to Start of Cryo Transfusion
Measured: procedure (Time from OR start time to start of cryo transfusion)
Time From Cryo Order to Start of Transfusion
Time to cryo order time to start of cryo transfusion
Measured: procedure (Time from cryo order to start of transfusion)
Number of Cryo Units Wasted by Blood Bank
This captures the Cryoprecipitate units discarded.
Measured: Daily, up to approximately 24 months
Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation
FIBTEM before transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.
Measured: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Post Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation
FIBTEM after transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.
Measured: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Maximum Clot Firmness (MCF)
The maximum strength of a clot as determined by ROTEM testing.
Measured: Variable, but it is generally available within 1 hour of the start of ROTEM testing.
Pre-transfusion Fibrinogen Level
The fibrinogen measurement before cryoprecipitate is transfused.
Measured: During surgery, within 3 hours of specimen receipt by laboratory.
Highest Fibrinogen Level Within 24 Hours
Measured: Within 24 hours after surgery
Lowest Fibrinogen Level Within 24 Hours
Measured: Within 24 hours after surgery
Cumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal
The cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of drain removal
Measured: Up to approximately 3 days
Volume in Drains (Chest Tube for CV Surgery)
Measured: At 24 hours after surgery
Time From End of Bypass Pump for CV Surgery
Measured: Until end of surgery
Length of Stay in OR
Operating room length of stay
Measured: Duration of time in operating room
Length of Stay in ICU
Participant length of stay in ICU setting
Measured: During hospitalization, approximately 5 days to 30 days
Length of Stay in Hospital
Overall length of stay in hospital
Measured: During hospitalization, approximately 5 days to 30 days
Need for Ventilator
Measured: During hospitalization, approximately 5 days to 30 days
Time on Ventilator
If participant was on ventilator, amount of time spent on ventilator
Measured: During hospitalization, approximately 5 days to 30 days
Overall Cost of Cryo vs PR Cryo, When Factoring Wastage
Cost of traditional cryoprecipitate compared to PR Cryoprecipitate.
Measured: Daily, approximately 24 months
Number of Participants That Experienced an Adverse Event of Fever
All participants that experience fevers that occur during the time frame
Measured: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Infection
All participants that experience infections that occur during the time frame
Measured: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Transfusion Reaction.
All participants that experience transfusion reactions that occur during the time frame
Measured: Within 5 days of surgery start time
Fibrinogen Level
Fibrinogen level most proximal to the end of surgery
Measured: Most proximal to end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Apr 2023
- Primary completion23 Oct 2024
- Study completion3 Oct 2025
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 (10)Papers the sponsor has linked to this study.
- Other trials for HypofibrinogenemiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Model description
- The intervention and randomization are not made at the level of the individual patient, but rather on clusters of patients by month. The clusters will include all patients at NYP/WC for whom pooled cryo is ordered during a single month.
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Cerus Corporation
- Responsible party
- Sponsor
- Investigators
- Melissa Cushing, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711524
- Sponsor's protocol ID
- 22-04024649
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2023
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials. J Clin Epidemiol. 2016 Jun;74:40-50. doi: 10.1016/j.jclinepi.2015.11.013. Epub 2015 Nov 26.
PubMed 26633599Saland LC. Effects of reserpine administration on the fine structure of the rat pars intermedia. Cell Tissue Res. 1978 Nov 9;194(1):115-23. doi: 10.1007/BF00209237.
PubMed 719724Cushing MM, Fitzgerald MM, Harris RM, Asmis LM, Haas T. Influence of cryoprecipitate, Factor XIII, and fibrinogen concentrate on hyperfibrinolysis. Transfusion. 2017 Oct;57(10):2502-2510. doi: 10.1111/trf.14259. Epub 2017 Jul 21.
PubMed 28734018Cushing MM, Haas T, Karkouti K, Callum J. Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia-cryoprecipitate or fibrinogen concentrate? Transfusion. 2020 Jun;60 Suppl 3:S17-S23. doi: 10.1111/trf.15614. Epub 2020 Jun 1.
PubMed 32478877Fenderson JL, Meledeo MA, Rendo MJ, Peltier GC, McIntosh CS, Davis KW, Corley JB, Cap AP. Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. Transfusion. 2019 Apr;59(S2):1560-1567. doi: 10.1111/trf.15180.
PubMed 30980741Bulkley GB, Wheaton LG, Strandberg JD, Zuidema GD. Assessment of small intestinal recovery from ischemic injury after segmental, arterial, venous, and arteriovenous occlusion. Surg Forum. 1979;30:210-3. No abstract available.
PubMed 538597Hsien S, Dayton JD, Chen D, Stock A, Bacha E, Cushing MM, Nellis ME. Hemostatic efficacy of pathogen-reduced platelets in children undergoing cardiopulmonary bypass. Transfusion. 2022 Feb;62(2):298-305. doi: 10.1111/trf.16768. Epub 2021 Dec 13.
PubMed 34904250Lokhandwala PM, O'Neal A, Patel EU, Brunker PAR, Gehrie EA, Zheng G, Kickler TS, Ness PM, Tobian AAR. Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing. Transfusion. 2018 May;58(5):1126-1131. doi: 10.1111/trf.14550. Epub 2018 Feb 25.
PubMed 29479708Thomson C, Sobieraj-Teague M, Scott D, Duncan E, Abraham S, Roxby D. Extending the post-thaw viability of cryoprecipitate. Transfusion. 2021 May;61(5):1578-1585. doi: 10.1111/trf.16366. Epub 2021 Mar 17.
PubMed 33728705Cushing MM, Cohen T, Fitzgerald MM, Rand S, Sinfort A, Chen D, Keltner N, Ong S, Parra P, Benabdessadek D, Jimenez A, Haas T, Lau C, Girardi NI, DeSimone RA. Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial. Trials. 2024 Sep 27;25(1):625. doi: 10.1186/s13063-024-08398-x.
PubMed 39334317
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen (INTERCEPT Fibrinogen Complex) in Patients With Bleeding to Expedite Product Availability and Improve Outcomes in Perioperative Bleeding
- ClinicalTrials.gov ID
- NCT05711524
- Acronym / sponsor ID
- 22-04024649
- Conditions
- Hypofibrinogenemia, Bleeding
- Keywords
- Cryoprecipitate, Pathogen Reduced Cryoprecipitate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Cerus Corporation
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided.
Participants will be given one of the two FDA-approved blood products.
Detailed description
Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used for fibrinogen replacement in the US, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . A modified version of the product, pathogen reduced (PR) cryo, is now FDA approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. In this quality improvement study, the investigators will compare the effect that readily available, pre-thawed PR cryo has on transfusion practice in cardiovascular and liver transplant patients who receive PR cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all PR cryo. All clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention and randomization are not made at the level of the individual patient, but rather on clusters of patients by month. The clusters will include all patients at NYP/WC for whom pooled cryo is ordered during a single month.
| Arm | Type | Receives |
|---|---|---|
| Patients given Traditional Cryo | Active comparator | Biological: Traditional CryoprecipitateThese are the liver transplant and cardiothoracic (LT and CT) patients that will be given traditional cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month. |
| Patients given PR Cryo | Experimental | Biological: Pathogen-Reduced CryoprecipitateThese are the liver transplant and cardiothoracic (LT and CT) patients that will be given PR cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
- Cardiovascular surgery includes the following procedures:
Key exclusion criteria (8 listed)
- Patients who do not receive any cryo product in the OR
- Patients who are not cardiovascular surgery or liver transplant patients
- Cardiac transplantation surgery
- Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month.
- Patients who receive less than 1 pool (5 units) of cryo
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 |
|---|---|---|
| Traditional CryoprecipitateThis is the cryoprecipitate already currently being given to patients with a cryo order. | Biological | Patients given Traditional Cryo |
| Pathogen-Reduced CryoprecipitateThis is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate. | Biological | Patients given PR Cryo |
Primary outcome
Total Number of RBCs Used Over Admission
Time frame: Within the first 30 days after surgery.
RBCs used over admission
Total Number of Platelets Used Over Admission
Time frame: Within the first 30 days after surgery.
Plts used over admission
Total Number of Plasma Used Over Admission
Time frame: Within the first 30 days after surgery.
All units over admission
26 secondary outcomes
Number of Cryo Units Used Perioperatively
Time frame: 3 days post procedure
Number of RBCs Used Perioperatively
Time frame: 3 days post procedure
Number of Plasma Used Perioperatively
Time frame: 3 days post procedure
Number of Platelets Used Perioperatively
Time frame: 3 days post procedure
Time From Operating Room (OR) Start Time to Start of Cryo Transfusion
Time frame: procedure (Time from OR start time to start of cryo transfusion)
Time From Cryo Order to Start of Transfusion
Time frame: procedure (Time from cryo order to start of transfusion)
Number of Cryo Units Wasted by Blood Bank
Time frame: Daily, up to approximately 24 months
Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation
Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Post Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation
Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Maximum Clot Firmness (MCF)
Time frame: Variable, but it is generally available within 1 hour of the start of ROTEM testing.
Pre-transfusion Fibrinogen Level
Time frame: During surgery, within 3 hours of specimen receipt by laboratory.
Highest Fibrinogen Level Within 24 Hours
Time frame: Within 24 hours after surgery
Lowest Fibrinogen Level Within 24 Hours
Time frame: Within 24 hours after surgery
Cumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal
Time frame: Up to approximately 3 days
Volume in Drains (Chest Tube for CV Surgery)
Time frame: At 24 hours after surgery
Time From End of Bypass Pump for CV Surgery
Time frame: Until end of surgery
Length of Stay in OR
Time frame: Duration of time in operating room
Length of Stay in ICU
Time frame: During hospitalization, approximately 5 days to 30 days
Length of Stay in Hospital
Time frame: During hospitalization, approximately 5 days to 30 days
Need for Ventilator
Time frame: During hospitalization, approximately 5 days to 30 days
Time on Ventilator
Time frame: During hospitalization, approximately 5 days to 30 days
Overall Cost of Cryo vs PR Cryo, When Factoring Wastage
Time frame: Daily, approximately 24 months
Number of Participants That Experienced an Adverse Event of Fever
Time frame: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Infection
Time frame: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Transfusion Reaction.
Time frame: Within 5 days of surgery start time
Fibrinogen Level
Time frame: Most proximal to end of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26633599Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials. J Clin Epidemiol. 2016 Jun;74:40-50. doi: 10.1016/j.jclinepi.2015.11.013. Epub 2015 Nov 26.
- Background: PubMed 719724Saland LC. Effects of reserpine administration on the fine structure of the rat pars intermedia. Cell Tissue Res. 1978 Nov 9;194(1):115-23. doi: 10.1007/BF00209237.
- Background: PubMed 28734018Cushing MM, Fitzgerald MM, Harris RM, Asmis LM, Haas T. Influence of cryoprecipitate, Factor XIII, and fibrinogen concentrate on hyperfibrinolysis. Transfusion. 2017 Oct;57(10):2502-2510. doi: 10.1111/trf.14259. Epub 2017 Jul 21.
- Background: PubMed 32478877Cushing MM, Haas T, Karkouti K, Callum J. Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia-cryoprecipitate or fibrinogen concentrate? Transfusion. 2020 Jun;60 Suppl 3:S17-S23. doi: 10.1111/trf.15614. Epub 2020 Jun 1.
- Background: PubMed 30980741Fenderson JL, Meledeo MA, Rendo MJ, Peltier GC, McIntosh CS, Davis KW, Corley JB, Cap AP. Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. Transfusion. 2019 Apr;59(S2):1560-1567. doi: 10.1111/trf.15180.
- Background: PubMed 538597Bulkley GB, Wheaton LG, Strandberg JD, Zuidema GD. Assessment of small intestinal recovery from ischemic injury after segmental, arterial, venous, and arteriovenous occlusion. Surg Forum. 1979;30:210-3. No abstract available.
- Background: PubMed 34904250Hsien S, Dayton JD, Chen D, Stock A, Bacha E, Cushing MM, Nellis ME. Hemostatic efficacy of pathogen-reduced platelets in children undergoing cardiopulmonary bypass. Transfusion. 2022 Feb;62(2):298-305. doi: 10.1111/trf.16768. Epub 2021 Dec 13.
- Background: PubMed 29479708Lokhandwala PM, O'Neal A, Patel EU, Brunker PAR, Gehrie EA, Zheng G, Kickler TS, Ness PM, Tobian AAR. Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing. Transfusion. 2018 May;58(5):1126-1131. doi: 10.1111/trf.14550. Epub 2018 Feb 25.
- Background: PubMed 33728705Thomson C, Sobieraj-Teague M, Scott D, Duncan E, Abraham S, Roxby D. Extending the post-thaw viability of cryoprecipitate. Transfusion. 2021 May;61(5):1578-1585. doi: 10.1111/trf.16366. Epub 2021 Mar 17.
- Derived from this study: PubMed 39334317Cushing MM, Cohen T, Fitzgerald MM, Rand S, Sinfort A, Chen D, Keltner N, Ong S, Parra P, Benabdessadek D, Jimenez A, Haas T, Lau C, Girardi NI, DeSimone RA. Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial. Trials. 2024 Sep 27;25(1):625. doi: 10.1186/s13063-024-08398-x.
- Individual participant dataSharing planned: No
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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.
Melissa Cushing principal investigator
Weill Medical College of Cornell University
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 Traditional Cryoprecipitate and Pathogen-Reduced Cryoprecipitate in people with Hypofibrinogenemia and Bleeding, run by Weill Medical College of Cornell University 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 8 inclusion and 8 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 21 Nov 2025. 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 21 Nov 2025). 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?
Total Number of RBCs Used Over Admission (time frame: Within the first 30 days after surgery.). The study lists 3 primary outcomes in all. 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 NCT05711524, which also lists 10 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 21 Nov 2025.