CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
Fibrinogen Concentrate (FC) +1 moredrug
Likely dose
Fibrinogen Concentrate (FC) 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03932240
NCT03932240Phase 3Completed
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In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)

Emory University·interventional·Posted Apr 30, 2019·Updated Feb 20, 2024

In Brief

A Phase 3 clinical trial evaluating Fibrinogen Concentrate (FC) and Cryoprecipitate for Hemostasis. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 30, 2019
Enrollment StartAug 13, 2019
Primary CompletionApr 9, 2021
Study CompletionNov 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.2 years ago

Interventions

Fibrinogen Concentrate (FC)drug

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.