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

Phase 4

Completed

Conditions: Hemophilia A
coagulation disorder
10064477
10005330

Registration Number: NL-OMON47789

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: 75

Inclusion Criteria

In order to be eligible for this study, a subject must meet all of the
following 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

A potential subject who meets any of the following criteria will be excluded
from participation in this study:, - 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 , -
Use of co-medication that has an interaction with desmopressin , - Intolerance
to previous desmopressin administrations

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The average deviation of the measured FVIII level before the minor intervention<br /><br>to the predicted peak FVIII values in IU/mL and the FVIII-concentrate<br /><br>consumptionfor the first 24 hours around the minor intervention.</p><br>

Secondary Outcome Measures

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