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Evaluating point-of-care prothrombin time measurements for cardiac surgery

Completed
Conditions
prothrombin time
coagulation status
10064477
10007593
Registration Number
NL-OMON40525
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
64
Inclusion Criteria

Ex-vivo study
- Healthy volunteers
- Age 18 * 90 years
- Informed consent;Clinical study in cardiac surgery
- Patients undergoing elective cardiothoracic surgery
- Age 18-90 years
- Preoperative hemoglobin of > 5.5 mmol/l
- Informed consent

Exclusion Criteria

Ex vivo study
- Subjects with hemostatic deficiencies or previous hemostatic problems
- Subjects using vitamin K antagonists, clopidogrel or dabigatran at the time of surgery.
- Pregnancy;Clinical study in cardiac surgery
- Re-operations and emergency operations
- Use of erythropoietin
- Hepatic or renal failure

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The International Normalized Ratio (INR) of the prothrombin time (PT) as<br /><br>measured with Coaguchek Plus or routine laboratory tests.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The ex vivo effect of different protamine:heparin ratio on the POC-PT. </p><br>
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