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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56644
Enrollment
45
Registered
2024-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

aandoeningen met hartklep Aortic valve disease coronary artery disease

Interventions

3.4.1 Collection and processing blood The study population can be divided into three groups of 15 patients. This sub population has a certain wash volume of the ATS (700 ml, 1000 ml and 1300 ml). Th

Sponsors

Medisch Centrum Leeuwarden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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: 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 (

Design outcomes

Primary

MeasureTime frame
The aim of this pilot study is to understand more about possible residual heparin concentration in the ATS product. In addition, the relationship between wash quantity and residual fraction of heparin will be examined. The primary outcome of this study is the residual heparin fraction in the ATS product.

Secondary

MeasureTime frame
Secondary study parameters are the ROTEM values (coagulation management: INTEM, EXTEM, FIBTEM and HEPTEM), APTT values, ACT values, blood loss and blood transfusion. Study information will be obtained from each patient, represented in a form in the Appendix.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)