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Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

NCT01547728 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-07-15

Study results available
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Summary

The objective of this study is to prospectively evaluate the response of recombinant antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to undergo cardiac surgery.

Conditions

  • Thrombophilia Due to Acquired Antithrombin III Deficiency

Interventions

DRUG

Recombinant antithrombin (rhAT)

Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.

Sponsors & Collaborators

  • rEVO Biologics

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • William Oliver, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01547728 on ClinicalTrials.gov