Method comparison for the detection of residual heparin after cardiovascular surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003593

Enrollment

100

Registered

2012-12-05

Start date

2010-08-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T81.0 D68.30

Interventions

Group 1: Blood samples were drawn at three time points for coagulation screening tests 1. after induction of general anesthesia 2. after the termination of the cardiopulmonary bypass and administratio

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

—

Countries

Germany

Contacts

Public ContactSaskia Wand

Universitätsmedizin Göttingen Zentrum für Anästhesiologie, Rettungs- und Intensivmedizin

saskia.wand@med.uni-goettingen.de0551-39-8826

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026