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Understanding "Heparin Resistance" in Cardiac Surgery

NCT01598883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2016-12-14

No results posted yet for this study

Summary

This study will explore altered heparin responsiveness (AHR) in cardiac surgical patients undergoing cardiopulmonary bypass (CPB) requiring systemic anticoagulation with heparin. The investigators will evaluate the hypothesis that AHR may be directly related to, modulated or mediated by interactions between heparin, antithrombin (AT), the heparin-AT complex, and one or more acute phase proteins. The investigators are particularly interested in identifying patients with "true heparin resistance", that is, patients who demonstrate AHR even after antithrombin-replenishment in the presence of an adequate systemic dose of heparin.

Conditions

  • Cardiopulmonary Bypass
  • Altered Heparin Response

Interventions

DRUG

Heparin

150 U/kg

DRUG

ATryn

1000 IU

Sponsors & Collaborators

  • rEVO Biologics

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Greg Koski, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01598883 on ClinicalTrials.gov