Desmopressin and FVIII concentrate combination treatment in non-severe hemophilia A patients undergoing minor interventions

Recruiting

Conditions: Hemophilia A
Surgery
Pharmacokinetics
Desmopressin

Registration Number: NL-OMON26618

Lead Sponsor: Erasmus University Medical Center Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Non-severe hemophilia A patients (FVIII 0.01-0.40 IU/mL)
-In need of a minor surgical intervention
-Age minimally 12 and maximally 70 years at study inclusion date
-Need for perioperative FVIII concentrates for a maximum of 48 hours
-Having admissible results of a desmopressin test (see paragraph 3.1)
-Absolute increase in FVIII 1 hour after desmopressin administration = 0.2 IU/mL after a previous (test) dose
-Male gender
-(Parental) informed consent

Exclusion Criteria

-Patients with other congenital or acquired hemostatic abnormalities
-Clinically relevant FVIII inhibiting antibodies (>0.5 BU) preoperatively, unless successfully treated with immunotolerance therapy
-Needed treatment duration with FVIII concentrates longer than 48 hours
-Contraindications for desmopressin, e.g. cardiovascular disease (see appendix IV)
-Use of co-medication that has an interaction with desmopressin (see appendix IV)
-Intolerance to previous desmopressin administrations

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment, measured as the deviation of the measured FVIII from the predicted FVIII range preoperatively.<br /><br>The amount of FVIII concentrate in IU per kilogram

Secondary Outcome Measures

Name	Time	Method
a)Number and nature of bleeding during the first 14 days after the minor intervention (appendix VI)<br /><br>a)Other adverse events during the first 14 days after the minor intervention<br /><br>b)Treatment costs in both treatment arms<br /><br>c)The proportion of patients with FVIII plasma levels within set target levels after the minor intervention<br /><br>d)Experienced quality of care in participating patients<br /><br>e)Discrepancies between one-stage and chromogenic FVIII-measurements before and after desmopressin administration<br /><br>f)Inhibitor development 4-6 weeks after the minor intervention<br>