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Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass

NCT02037555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2019-03-15

Study results available
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Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III \[Human\]) supplementation prior to high-risk, non-emergency, cardiac surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who meet the study eligibility criteria were planned to be randomized to receive either AT-III (Human) or placebo.

Conditions

  • Cardiac Surgery
  • Cardiopulmonary Bypass

Interventions

BIOLOGICAL

AT-III (Human)

AT-III (Human) is an antithrombin concentrate prepared from pooled human plasma. AT-III (Human) is provided as a freeze-dried preparation for intravenous use. The AT-III (Human) preparation is reconstituted in 10 or 20 mL of sterile water for injection prior to intravenous administration.

OTHER

Placebo

0.9% Sodium Chloride for Injection, United States Pharmacopeia

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Clinipace Worldwide

    collaborator INDUSTRY

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-26
Primary Completion
2018-01-25
Completion
2018-01-25

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 NCT02037555 on ClinicalTrials.gov