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Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates

NCT01158729 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2014-01-20

No results posted yet for this study

Summary

A prospective, randomized, placebo-controlled, double-blinded pilot study is planned. Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III (ATIII) supplementation or placebo in addition to standard anticoagulation with heparin as currently practiced at Children's Hospital of Wisconsin. We plan to enroll the first 60 sequential patients meeting criteria who consent to inclusion. The primary outcomes will be rates of adverse events to monitor safety. Secondary outcomes include volume of postoperative blood loss and packed red blood cell transfusion during the first 24 postoperative hours, and ATIII levels during and after bypass to determine pharmacokinetics.

Conditions

  • Postoperative Hemorrhage

Interventions

DRUG

Antithrombin (Recombinant)

Single dose of antithrombin (recombinant) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: ATIII dose given to patient = \[(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg\] X (1 mL/175 Units)

OTHER

Placebo

Single dose of placebo (0.9% NaCl) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: Placebo dose given to patient = \[(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg\] X (1 mL/175 Units)

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • rEVO Biologics

    collaborator INDUSTRY

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Robert A Niebler, M.D. · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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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 NCT01158729 on ClinicalTrials.gov