The residual heparin concentration in the autotransfusion system product in cardiothoracic surgery: A pilot study

Withdrawn

• Conditions: aandoeningen met hartklep; Aortic valve disease; coronary artery disease; 10011082

• Registration Number: NL-OMON56644
• Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

The study population involves 45 patients undergoing on-pump CABG or/and AVR
procedure in the MCL, where ATS has been used. Male or female patients aged 18
years or older who were in a non-emergency situation are eligible.

Exclusion Criteria

Exclusion criteria includes patients who were using anticoagulant medication
prior to surgery, patients with preoperative known coagulation problems and
liver problems (increased APTT/ALAT/ASAT values in Electronic Health Record
(EHR)). Also, patients in which hypothermia (<34 degrees Celsius) is used
during cardiopulmonary bypass (CPB) are excluded from this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The aim of this pilot study is to understand more about possible residual<br /><br>heparin concentration in the ATS product. In addition, the relationship between<br /><br>wash quantity and residual fraction of heparin will be examined. The primary<br /><br>outcome of this study is the residual heparin fraction in the ATS product.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are the ROTEM values (coagulation management: INTEM,<br /><br>EXTEM, FIBTEM and HEPTEM), APTT values, ACT values, blood loss and blood<br /><br>transfusion. Study information will be obtained from each patient, represented<br /><br>in a form in the Appendix.</p><br>