HemostasisPhase 3NCT03932240

In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)

A Phase 3 study testing Fibrinogen Concentrate (FC) and Cryoprecipitate in people with Hemostasis, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for managing coagulopathies in neonates. Read more about this study

Who is it for?: Ages 1 day to 30 days
Conditions the study is for: Hemostasis
What is being tested?: Fibrinogen Concentrate (FC) and Cryoprecipitate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 13 Aug 2019to 16 Nov 2021
Phase: Phase 3
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 1 day to 30 days
All sexes
No healthy volunteers
Child

Who may be able to join

Full term neonates (36-42 weeks gestational age)
Infants =< 30 days of age at time of surgery
APGAR score of 6 or greater at 5 minutes after delivery
Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta
Parents willing to participate and able to understand and sign the provided informed consent

Who cannot join

Preterm neonates (less than 36 weeks gestation)
Patients undergoing an emergent procedure or surgery not requiring CPB
Patients with personal or family history of a coagulation defect or coagulopathy
Parents unwilling to participate or unable to understand and sign the provided informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Healthcare of Atlanta (CHOA), Egleston
Atlanta, Georgia, 30322

Other trials in United States

About this study

Read the detailed description

This study is a prospective, randomized control trial comparing two different sources of fibrinogen on clot kinetics (degradation and structure) in post-CPB coagulopathy in neonates undergoing cardiac surgery. The two sources of fibrinogen include the blood product, cryoprecipitate, and a blood product alternative, fibrinogen concentrate. Cryoprecipitate is an allogenic blood product that requires cross-matching and thawing prior to administration and is associated with immunologic reactions and possible pathogen transmission. Fibrinogen concentrate, a blood product alternative, is a purified form of fibrinogen, which undergoes a pasteurization process to minimize the risk of immunologic and allergic reactions. The primary aim of this study is compare the in vivo effect of post-CPB administration of FC, a blood product alternative, to cryoprecipitate on neonatal clot properties and clinical outcomes.

Conditions: Hemostasis
Being tested: Fibrinogen Concentrate (FC), Cryoprecipitate
Keywords: Fibrinogen Concentrate, FC, Cryoprecipitate, Transfusion, in vivo, Open-heart surgery, Cardiopulmonary Bypass, Fibrin Network Structure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fibrinogen Concentrate (FC)Drug
Also called RiaSTAP
The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.
CryoprecipitateDrug
The standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL.

Study groups in NCT03932240
Study group	Role	What they receive
Fibrinogen Concentrate (FC)	Experimental	Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and FC after separation from bypass. The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration. If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion. Receives: Drug: Fibrinogen Concentrate (FC)
Cryoprecipitate	Active comparator	Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and cryoprecipitate. Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL (based on findings by Downey et al., published in Anesthesia and Analgesia in 2020). If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion. Receives: Drug: Cryoprecipitate

What is being measured

The primary outcome is the main question the study is designed to answer.

Clot Degradation at 24 Hours Post-operatively
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery.
Measured: From induction of anesthesia to 24 hours postoperatively

Secondary outcomes (10)

Clot Strength
Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Strength will be assessed by rheology and atomic force microscopy (AFM).
Measured: From induction of anesthesia to 24 hours postoperatively
Clot Polymerization Kinetic
Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Polymerization will be determined by thrombin-initiated turbidity/absorbency curves.
Measured: From induction of anesthesia to 24 hours postoperatively
Fibrin Fiber Alignment
Clot structure is assessed by examination of images of clot fibrin fiber alignment. Quantification of clot fiber alignment was achieved through the application of an automated algorithm based on a fast Fourier transform that measures the alignment of the fibers, as well as visual inspection. A reference range has not been established for neonates, however, higher values indicate more dense clot structure.
Measured: From induction of anesthesia to 24 hours postoperatively
Interoperative Transfusion Requirement
Blood product transfusion requirements were obtained from electronic medical records. An increased transfusion requirement indicates increased interoperative bleeding, thus, lower values are preferable.
Measured: During surgery (up to 6 hours)
Transfusion Requirements Within the First 24 Hours After Surgery
Transfusion requirements within the first 24 hours of surgery were obtained from electronic medical records.
Measured: 24 hours postoperatively
Amount of Post-operative Bleeding
Post-operative bleeding was recorded by 24 hour chest tube output. Higher values indicate greater post-operative bleeding.
Measured: Up to 24 hours postoperatively
Mechanical Ventilation Time
Mechanical ventilation time was obtained from medical records. Higher values indicate increased need for mechanical ventilation.
Measured: Time of extubation (up to 2 weeks)
Length of ICU Stay
Length of ICU stay was obtained from medical records. A shorter ICU stay indicates a favorable state of health.
Measured: At discharge from ICU (typically up to 21 days)
Length of Hospital Stay
Length of hospital stay was obtained from medical records. A shorter hospital stay indicates a favorable state of health.
Measured: At discharge from hospital (up to 150 days)
Number of Adverse Events
Adverse events within seven days of surgery were obtained from medical records.
Measured: Within seven days of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 201916 Nov 2021

First posted30 Apr 2019
Study start13 Aug 2019
Primary completion9 Apr 2021
Study completion16 Nov 2021

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 (1)Papers the sponsor has linked to this study.
Other trials for HemostasisStudies of the same condition, open and under way.
More trials run by Emory 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03932240
Sponsor's protocol ID: IRB00109310
Status last verified: Jan 2024
First submitted: 3 Apr 2019
Last updated: 20 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), will be shared.

Publications

Downey LA, Moiseiwitsch N, Nellenbach K, Xiang Y, Brown AC, Guzzetta NA. Effect of In Vivo Administration of Fibrinogen Concentrate Versus Cryoprecipitate on Ex Vivo Clot Degradation in Neonates Undergoing Cardiac Surgery. Anesth Analg. 2025 Aug 1;141(2):240-251. doi: 10.1213/ANE.0000000000007123. Epub 2024 Aug 8.
PubMed 39116012

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis

All Hemostasis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
ClinicalTrials.gov ID: NCT03932240
Acronym / sponsor ID: IRB00109310
Conditions: Hemostasis
Keywords: Fibrinogen Concentrate, FC, Cryoprecipitate, Transfusion, in vivo, Open-heart surgery, Cardiopulmonary Bypass, Fibrin Network Structure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 13 Aug 2019 (actual)
Primary completion: 9 Apr 2021 (actual)
Study completion: 16 Nov 2021 (actual)
First posted: 30 Apr 2019 (actual)
Results: Posted 20 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fibrinogen Concentrate (FC)	Experimental	Drug: Fibrinogen Concentrate (FC)Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and FC after separation from bypass. The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration. If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.
Cryoprecipitate	Active comparator	Drug: CryoprecipitateNeonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and cryoprecipitate. Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL (based on findings by Downey et al., published in Anesthesia and Analgesia in 2020). If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.

Who may qualify

Ages: 1 day to 30 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Full term neonates (36-42 weeks gestational age)
Infants =< 30 days of age at time of surgery
APGAR score of 6 or greater at 5 minutes after delivery
Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta
Parents willing to participate and able to understand and sign the provided informed consent

Key exclusion criteria (4 listed)

Preterm neonates (less than 36 weeks gestation)
Patients undergoing an emergent procedure or surgery not requiring CPB
Patients with personal or family history of a coagulation defect or coagulopathy
Parents unwilling to participate or unable to understand and sign the provided informed consent

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
Fibrinogen Concentrate (FC)Also: RiaSTAPThe dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.	Drug	Fibrinogen Concentrate (FC)
CryoprecipitateThe standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL.	Drug	Cryoprecipitate

Primary outcome

Clot Degradation at 24 Hours Post-operatively
Time frame: From induction of anesthesia to 24 hours postoperatively
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery.

10 secondary outcomes

Clot Strength
Time frame: From induction of anesthesia to 24 hours postoperatively
Clot Polymerization Kinetic
Time frame: From induction of anesthesia to 24 hours postoperatively
Fibrin Fiber Alignment
Time frame: From induction of anesthesia to 24 hours postoperatively
Interoperative Transfusion Requirement
Time frame: During surgery (up to 6 hours)
Transfusion Requirements Within the First 24 Hours After Surgery
Time frame: 24 hours postoperatively
Amount of Post-operative Bleeding
Time frame: Up to 24 hours postoperatively
Mechanical Ventilation Time
Time frame: Time of extubation (up to 2 weeks)
Length of ICU Stay
Time frame: At discharge from ICU (typically up to 21 days)
Length of Hospital Stay
Time frame: At discharge from hospital (up to 150 days)
Number of Adverse Events
Time frame: Within seven days of surgery

Results and safety

Results posted to the registry on 20 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fibrinogen Concentrate (FC)	18	18
Cryoprecipitate	18	18

Primary outcome: Clot Degradation at 24 Hours Post-operatively

Time frame: From induction of anesthesia to 24 hours postoperatively. Median (Inter-Quartile Range). Unit: microns per hour

Measure	Fibrinogen Concentrate (FC) n = 18	Cryoprecipitate n = 18
After induction of anesthesia prior to CPB	0.65 (0.41 to 1.49)	0.88 (0.37 to 1.42)
After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	0.78 (0.33 to 0.92)	0.46 (0.27 to 1.56)
Upon arrival to the ICU	0.65 (0.44 to 0.88)	0.55 (0.28 to 2.39)
24 hours post-operatively	0.92 (0.55 to 1.42)	0.76 (0.34 to 1.22)

Population analysed: This analysis includes the Intent to Treat Population, which is comprised on all participants regardless of if they completed the study per protocol.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fibrinogen Concentrate (FC)	2 of 18 (11.1%)	4 of 18 (22.2%)	1 of 18
Cryoprecipitate	9 of 18 (50%)	6 of 18 (33.3%)	1 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39116012Downey LA, Moiseiwitsch N, Nellenbach K, Xiang Y, Brown AC, Guzzetta NA. Effect of In Vivo Administration of Fibrinogen Concentrate Versus Cryoprecipitate on Ex Vivo Clot Degradation in Neonates Undergoing Cardiac Surgery. Anesth Analg. 2025 Aug 1;141(2):240-251. doi: 10.1213/ANE.0000000000007123. Epub 2024 Aug 8.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), will be shared.

Related trials for Hemostasis

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis

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.

Laura Downey, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fibrinogen Concentrate (FC) and Cryoprecipitate in people with Hemostasis, run by Emory 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 5 inclusion and 4 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 20 Feb 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Mar 2023). 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?

Clot Degradation at 24 Hours Post-operatively (time frame: From induction of anesthesia to 24 hours postoperatively). 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 NCT03932240, which also lists 1 linked publication.

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 20 Feb 2024.