CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 57 enrolled
Drug / intervention
Fresh frozen plasma transfusionbiological
Likely dose
Fresh frozen plasma transfusion 5 unitsfrom 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/NCT02637427
NCT02637427Phase 3Completed
CompareCT.gov

Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Rutgers, The State University of New Jersey·interventional·Posted Dec 22, 2015·Updated Aug 18, 2021

In Brief

A Phase 3 clinical trial evaluating Fresh frozen plasma transfusion for Blood Coagulation Disorders and Hemorrhage. Completed, enrolled 57 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Coagulation Disorders, Hemorrhage
CountriesUnited States
CollaboratorsUniversity of Pittsburgh, Johns Hopkins University, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartFeb 26, 2016
Primary CompletionJun 28, 2019
Study CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.5 years ago

Interventions

Fresh frozen plasma transfusionbiological

Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)