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Protamine in Cardiac Surgery and Haemostasis

NCT01608971 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2017-03-27

Study results available
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Summary

Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a protamine regimen based on the initial heparin dose before CPB might lead to overdose of protamine. In contrast, a protamine regimen based on the actual heparin concentration may avoid this condition. The investigators compare both regimens of protamine dosing in patients undergoing complex surgery with CPB and assess its effect on the amount of protamine given, markers of the coagulation system, utilization of blood products and perioperative blood loss.

Conditions

Sponsors & Collaborators

  • Heart and Diabetes Center North-Rhine Westfalia

    lead OTHER

Principal Investigators

  • Andreas Koster, MD · Heart & Diabetes Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT01608971 on ClinicalTrials.gov