NL-OMON54546
Recruiting
Not Applicable
Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To Wi
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 160
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- No minimum or maximum age at inclusion date;
- •\- Hemorrhagic symptoms or a family history of von Willebrand disease with
- •historically lowest levels of VWF:Ag \<0\.60 IU/ml and/or VWF:Act \<0\.60 IU/ml
- •and/or VWF:CB \<0\.60 and/or FVIII \<0\.40 IU/ml;
- •\- Need for DDAVP\-testing (arm A); and/or
- •\- Need for a medical intervention requiring DDAVP and/or VWF replacement
- •therapy (arm B) (arm B); or
- •\- (Future) Bleeding requiring DDAVP and/or VWF replacement therapy (arm C); or
- •\- Receiving or requiring prophylaxis with VWF\-containing concentrate due severe
- •and/or recurrent bleeding episode (arm D).
Exclusion Criteria
- •\- Any other known hemostatic abnormalities;
- •\- Acquired VWD;
- •\- Presence of VWF antibodies (\>0\.2 BU)
- •\- Withdrawal of (parental) informed consent.
Outcomes
Primary Outcomes
Not specified
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