MedPath

Target Activated Clotting Time for anticoagulation during cardiopulmonary bypass

Recruiting
Conditions
bloodtransfusion
packed red blood cel transfusion
10011082
Registration Number
NL-OMON52711
Lead Sponsor
Perfusie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
1010
Inclusion Criteria

Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass
including coronary artery bypass grafting, valve surgery or a combination of
both.
Informed consent.

Exclusion Criteria

re-operations
aorta surgery
emergency operation
minimized extracorporeal circuits
deep hypothermia (<32 degrees Celsius)
patients with congenital or aquired coagulation factor abnormatlities
patients with anemia (hemoglobin values < 6.5 mmol/l)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Overall packed red blood cell transfusion rate during hospitalization.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>• 12 and 24-hour blood loss assessed by wound drainage<br /><br>• Postoperative hemoglobin values at 1, 12 and 24 hours following surgery<br /><br>• Reoperations due to bleeding<br /><br>• Late tamponade<br /><br>• Transfusion requirements (FFP, platelets, fibrinogen, PCC)<br /><br>• Postoperative hemostatic parameters<br /><br>• Use of preoperative anticoagulant medication<br /><br>• Number of patients who do not reach the target ACT after the first heparin<br /><br>dose<br /><br>• Total heparin and protamine dosing<br /><br>• Postoperative restenosis of grafts<br /><br>• Clotting of the extracorporeal circuit<br /><br>• Thromboembolic events during and following surgery (e.g. venous thrombosis,<br /><br>pulmonary embolism)<br /><br>• Mortality at 30 days, 90 days and 1 year following surgery<br /><br>• Patient demographics</p><br>
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