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Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

NCT02637427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-08-18

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Fresh frozen plasma transfusion

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

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Jeffrey L Carson, MD · Rutgers Robert Wood Johnson Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-26
Primary Completion
2019-06-28
Completion
2020-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637427 on ClinicalTrials.gov