Human Fibrinogen Concentrate in Pediatric Cardiac Surgery (RiaSTAP)

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

Status and phase: Completed; Phase 4

Conditions: Hypofibrinogenemia; Bleeding Disorders; Afibrinogenemia

Treatments: Drug: Saline; Drug: RiaStAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02822599

NCH0000201496

Details and patient eligibility

About

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.

Full description

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. RiaSTAP will be administered after termination of Cardiopulmonary Bypass (CPB) at a dose of 70 mg/kg, in a prospective, randomized, controlled study. We hypothesize that the administration of RiaSTAP in this manner will reduce peri-operative bleeding and transfusion requirements.

Enrollment: 30 patients

Sex: All

Ages: 1 day to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

RiaSTAP

Active Comparator group

Description:

Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.

Treatment:

Drug: RiaStAP

Saline

Placebo Comparator group

Description:

Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.

Treatment:

Drug: Saline