Method comparison for the detection of residual heparin after cardiovascular surgery

• Conditions: T81.0; D68.30; Haemorrhage and haematoma complicating a procedure, not elsewhere classified

• Registration Number: DRKS00003593
• Lead Sponsor: niversitätsmedizin GöttingenZentrum für Anästhesiologie, Rettungs- und Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-10-31
• Study Start: 2012-12-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

ASA risk classification II-IV
operation with the necessitiy of a cardio-pulmonary bypass

Exclusion Criteria

ASA risk classification V;
need for an assist device at the end of the operation with the need for continuous heparin therapy ( ECMO, LVAD, RVAD, BVAD);
patients with an anticoagulation with low molecular weight heparin prior to the operation;
patients with an allergy to protamin;
patients with a known heparin induced thrombocytopenia typ II

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual heparin measured by an elevated Anti-FactorXa-Activity after the termination of cardio-pulmonary-bypass and administration of protamin, as well as after the administration of the collected woundblood.

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, negativ and positiv predictive value of standard laboratory measurements with thromboplastin time, activated partial thromboplastin time (aPTT), thrombin time (TT), fibrinogen concentration and platelet count for the identification of residual heparin after the termination of CPB and administration of protamin as well as after the administration of the collected woundblood.<br>Sensitivity, specificity, negativ and positiv predictive value of Point-of-Care (POC) diagnostics for the identification of residual heparin at both time points with clotting time (CT) in the INTEM and in the HEPTEM test, heparin-protamin-titration measured with Hepcon® HMS Plus and activated clotting time (ACT) measured with Haemochron® Jr. Signature and Hepcon® HMS Plus.