Trial · NCT03932240

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

NCT03932240, Phase 3, Completed, Emory University; results first posted 2023-03-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB). Trials, record NCT03932240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03932240

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
NCT number: NCT03932240
Status: Completed
Phases: Phase 3
Enrollment: 36 participants, actual
Lead sponsor: Emory University
Conditions: Hemostasis
Interventions: Fibrinogen Concentrate (FC), Cryoprecipitate
First posted: 2019-04-30
Last updated: 2024-02-20
Results first posted: 2023-03-20

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clot Degradation at 24 Hours Post-operatively	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.
Secondary	Clot Strength	From induction of anesthesia to 24 hours postoperatively	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).
Secondary	Clot Polymerization Kinetic	From induction of anesthesia to 24 hours postoperatively	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.
Secondary	Fibrin Fiber Alignment	From induction of anesthesia to 24 hours postoperatively	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.
Secondary	Interoperative Transfusion Requirement	During surgery (up to 6 hours)	Blood product transfusion requirements were obtained from electronic medical records. An increased transfusion requirement indicates increased interoperative bleeding, thus, lower values are preferable.
Secondary	Transfusion Requirements Within the First 24 Hours After Surgery	24 hours postoperatively	Transfusion requirements within the first 24 hours of surgery were obtained from electronic medical records.
Secondary	Amount of Post-operative Bleeding	Up to 24 hours postoperatively	Post-operative bleeding was recorded by 24 hour chest tube output. Higher values indicate greater post-operative bleeding.
Secondary	Mechanical Ventilation Time	Time of extubation (up to 2 weeks)	Mechanical ventilation time was obtained from medical records. Higher values indicate increased need for mechanical ventilation.
Secondary	Length of ICU Stay	At discharge from ICU (typically up to 21 days)	Length of ICU stay was obtained from medical records. A shorter ICU stay indicates a favorable state of health.
Secondary	Length of Hospital Stay	At discharge from hospital (up to 150 days)	Length of hospital stay was obtained from medical records. A shorter hospital stay indicates a favorable state of health.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clot Degradation at 24 Hours Post-operatively	From induction of anesthesia to 24 hours postoperatively	This analysis includes the Intent to Treat Population, which is comprised on all participants regardless of if they completed the study per protocol.	microns per hour	MEDIAN
SECONDARY	Clot Strength	From induction of anesthesia to 24 hours postoperatively	Unfortunately, due to the required amount of blood necessary for triplicates of the primary outcome, there was not enough blood to examine clot strength. Due to the small amount of blood collected from neonates the samples were used for the outcome measures with the highest priority and the amount of remaining blood was not sufficient to assess clot strength.
SECONDARY	Clot Polymerization Kinetic	From induction of anesthesia to 24 hours postoperatively	Due to the maximum allowable blood to be taken from a neonate, there was not enough remaining blood available to examine clot polymerization kinetics. In order to carry out the degradation assay on neonatal fibrinogen, the study team improved the assay they originally intended to use and no longer did polymerization assays as part of the degradation assay. Due to the change in the degradation assay, the team was not able to collect additional blood for the clot polymerization kinetics assay.
SECONDARY	Fibrin Fiber Alignment	From induction of anesthesia to 24 hours postoperatively	This analysis includes the Intent to Treat Population.	black/white pixels	MEDIAN
SECONDARY	Interoperative Transfusion Requirement	During surgery (up to 6 hours)	This analysis includes the Intent to Treat Population.	ml/kg	MEDIAN
SECONDARY	Transfusion Requirements Within the First 24 Hours After Surgery	24 hours postoperatively	The recording of transfusions in the intensive care unit (ICU) changed in the middle of this study and therefore transfusions were not consistently documented by the clinical staff, thus, the study investigators decided to not collect information about transfusions up to 24 hours after surgery from medical records as data could not be reliably analyzed.
SECONDARY	Amount of Post-operative Bleeding	Up to 24 hours postoperatively	This analysis includes the Intent to Treat Population.	ml/kg	MEDIAN
SECONDARY	Mechanical Ventilation Time	Time of extubation (up to 2 weeks)	This analysis includes the Intent to Treat Population.	hours	MEDIAN
SECONDARY	Length of ICU Stay	At discharge from ICU (typically up to 21 days)	This analysis includes the Intent to Treat Population.	days	MEDIAN
SECONDARY	Length of Hospital Stay	At discharge from hospital (up to 150 days)	This analysis includes the Intent to Treat Population.	days	MEDIAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Clot Degradation at 24 Hours Post-operatively	Fibrinogen Concentrate (FC)	After induction of anesthesia prior to CPB	0.65	Inter-Quartile Range 0.41 to 1.49	microns per hour
Clot Degradation at 24 Hours Post-operatively	Cryoprecipitate	After induction of anesthesia prior to CPB	0.88	Inter-Quartile Range 0.37 to 1.42	microns per hour
Clot Degradation at 24 Hours Post-operatively	Fibrinogen Concentrate (FC)	After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	0.78	Inter-Quartile Range 0.33 to 0.92	microns per hour
Clot Degradation at 24 Hours Post-operatively	Cryoprecipitate	After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	0.46	Inter-Quartile Range 0.27 to 1.56	microns per hour
Clot Degradation at 24 Hours Post-operatively	Fibrinogen Concentrate (FC)	Upon arrival to the ICU	0.65	Inter-Quartile Range 0.44 to 0.88	microns per hour
Clot Degradation at 24 Hours Post-operatively	Cryoprecipitate	Upon arrival to the ICU	0.55	Inter-Quartile Range 0.28 to 2.39	microns per hour
Clot Degradation at 24 Hours Post-operatively	Fibrinogen Concentrate (FC)	24 hours post-operatively	0.92	Inter-Quartile Range 0.55 to 1.42	microns per hour
Clot Degradation at 24 Hours Post-operatively	Cryoprecipitate	24 hours post-operatively	0.76	Inter-Quartile Range 0.34 to 1.22	microns per hour
Fibrin Fiber Alignment	Fibrinogen Concentrate (FC)	After induction of anesthesia prior to CPB	0.46	Inter-Quartile Range 0.26 to 0.61	black/white pixels
Fibrin Fiber Alignment	Cryoprecipitate	After induction of anesthesia prior to CPB	0.54	Inter-Quartile Range 0.32 to 0.68	black/white pixels

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fibrinogen Concentrate (FC)	18
Overall Study	STARTED	Cryoprecipitate	18
Overall Study	Completed Study Per Protocol	Fibrinogen Concentrate (FC)	17
Overall Study	Completed Study Per Protocol	Cryoprecipitate	13
Overall Study	COMPLETED	Fibrinogen Concentrate (FC)	18
Overall Study	COMPLETED	Cryoprecipitate	18
Overall Study	NOT COMPLETED	Fibrinogen Concentrate (FC)	0
Overall Study	NOT COMPLETED	Cryoprecipitate	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Arrhythmia	Cardiac disorders	Fibrinogen Concentrate (FC)	2	18
other	Arrhythmia	Cardiac disorders	Cryoprecipitate	4	18
other	Thrombosis	Vascular disorders	Fibrinogen Concentrate (FC)	2	18
other	Thrombosis	Vascular disorders	Cryoprecipitate	2	18
serious	Extracorporeal membrane oxygenation (ECMO) within 24 hours	Surgical and medical procedures	Fibrinogen Concentrate (FC)	0	18
serious	Extracorporeal membrane oxygenation (ECMO) within 24 hours	Surgical and medical procedures	Cryoprecipitate	4	18
serious	Tamponade	Surgical and medical procedures	Fibrinogen Concentrate (FC)	0	18
serious	Tamponade	Surgical and medical procedures	Cryoprecipitate	1	18
serious	Chest exploration	Surgical and medical procedures	Fibrinogen Concentrate (FC)	1	18
serious	Chest exploration	Surgical and medical procedures	Cryoprecipitate	2	18

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fibrinogen Concentrate (FC)	1	18
Total, all-cause mortality	Cryoprecipitate	1	18
Total, other adverse events	Fibrinogen Concentrate (FC)	4	18
Total, other adverse events	Cryoprecipitate	6	18
Total, serious adverse events	Fibrinogen Concentrate (FC)	2	18
Total, serious adverse events	Cryoprecipitate	9	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39116012	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fibrinogen Concentrate (FC) vs Cryoprecipitate: deaths from any cause	Trial comparisons
Fibrinogen Concentrate (FC) vs Cryoprecipitate: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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