Human Fibrinogen Concentrate in Pediatric Cardiac Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders

In brief

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.

Key facts

Study ID

NCT02822599

Run by

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

People needed

30

Starts

2017-06-01

Expected to finish

2020-12-24

Last updated by the study team

2021-09-16

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus Children's Hospital will be eligible for enrollment in the study.

You may not qualify if…

• Patients who fall outside of the age range for the study will be excluded. Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM MCF > 15mm, will be excluded.

Where it is running

• Nickalus Children's Hospital f/k/a Miami Children's Hospital — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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