Efficacy and safety of Haemocomplettan® P in patients experiencing microvascular bleeding while undergoing elective complex cardiac surgery

Phase 2

Completed

• Conditions: bleeding; microvascular bleeding during complex cardiac surgery; 10007593

• Registration Number: NL-OMON34087
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Eighteen years of age or older.
Undergoing elective complex cardiac surgery (CABG and valve(s) or multiple valves or aortic root, aorta ascendens or aortic arch surgery).
Understood and willingly given written informed consent (Dutch language) to participate following an explanation of study background, restrictions, and procedures.
Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery (clinically relevant microvascular bleeding defined as a 5-minute bleeding mass between 60 and 250 g)
Intraoperative conditions prior to administration of study medication are:
- Body temperature > 36°C
- Blood pH > 7.3
- Hb > 5.3 mmol/L or Ht > 0.25
- ACT < 140 seconds

Exclusion Criteria

•Positive pregnancy test, pregnancy or lactation.
•Women of child-bearing age not using a medically approved method of contraception during the study.
•Undergoing an emergency operation.
•Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease).
•Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery.
•Manifest venous or arterial thrombosis.
•Medication:
-Clopidogrel administration in the 5 days preceding surgery.
-Tirofiban administration in the 2 days preceding surgery.
-INR >1.4 if on coumadines.
•Participation in another clinical study in the 4 weeks preceding this study.
•Sensitivity to any of the components of study medication.
•Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude).
•Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given.
•Multiple morbidities, with a notably constrained remaining length of life.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Perioperative blood loss measured as blood loss in ml between infusion of study<br /><br>medication and closure of chest.</p><br>