OPTI-CLOT: Peri-OPerative pharmacokineTIc-guided dosing of CLOTting factor in hemophilia

Completed

Conditions: abnormal clot formation
bleeding disorder
10005330

Registration Number: NL-OMON47823

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

- Severe and moderate hemophilia A (FVIII plasma level *5%)
- Elective and low or medium risk surgery as defined by surgical risk score
- * 12 years of age at inclusion date for the randomized controlled trial
- <12 years of age at inclusion date for the PK-guided dosing observational
children cohort
- Written informed consent.

Exclusion Criteria

- Patients with other congenital or acquired hemostatic abnormalities.
- Withdrawal of (parental) informed consent.
- Detectable FVIII inhibiting antibodies (>0,2 BU) at inclusion in study.
- General medical conditions which may interfere with participation in the
study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Total amount of infused FVIII concentrate (IU) per kilogram body weight during<br /><br>peri-operative period per post-operative day (0-14 days after surgery). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Peri-operative hemostasis as quantified by hemoglobin values pre- and<br /><br>postoperative, blood loss and classification of expected blood loss during<br /><br>surgical procedure as documented by standardized form.<br /><br>2. Achieved FVIII levels after FVIII infusion (IU ml-1)<br /><br>3. Length of hospitalization (days).<br /><br>4. Effect of baseline VWF antigen, propeptide values and blood type on FVIII<br /><br>clearance.<br /><br>5. Economic evaluation.</p><br>