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Human Fibrinogen Concentrate in Pediatric Cardiac Surgery

NCT02822599 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-16

Study results available
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Summary

The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.

Conditions

Interventions

DRUG

RiaStAP

To decrease post-operative bleeding volume.

DRUG

Saline

Placebo consisting of normal saline 0.9%

Sponsors & Collaborators

  • Nicklaus Children's Hospital f/k/a Miami Children's Hospital

    lead OTHER

Principal Investigators

  • Christopher Tirotta, MD · Director Cardiac Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-08-26
Completion
2020-12-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02822599 on ClinicalTrials.gov