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Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

NCT00823082 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-09-20

Study results available
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Summary

The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.

Conditions

  • Acquired Antithrombin III Deficiency
  • Coronary Artery Bypass

Interventions

DRUG

Antithrombin III

Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    lead INDUSTRY

Principal Investigators

  • Marco Ranucci, MD · IRCCS Policlinico San Donato, Milano

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • Italy

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 NCT00823082 on ClinicalTrials.gov