DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A

Recruiting

Conditions: hemophilia A
hemofilie Adesmopressin
chirurgiepharmacokinetics
desmopressinesurgery
farmacokinetiek

Registration Number: NL-OMON23569

Lead Sponsor: Erasmus 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 IU/mL)
-In need of surgery or suffering from bleeding
-Age minimally 12 and maximally 70 years at study inclusion date
-Need for clotting factor concentrates
-Treatment duration with FVIII-concentrates of at least 48 hours
-Results of FVIII levels after a DDAVP test dose, or if test results are not available, willingness to undergo a DDAVP test
-Male gender
-(Parental) informed consent

Exclusion Criteria

-Patients with other congenital or acquired hemostatic abnormalities
-Very low response to DDAVP after 1 hour – absolute increase in FVIII < 0.2 IU/mL
-Clinically relevant FVIII inhibiting antibodies (>0.5 BU) preoperatively, unless successfully treated with immunotolerance therapy
-Contraindications for DDAVP, e.g. cardiovascular disease (see appendix IV)
-Use of co-medication that has an interaction with DDAVP (see appendix IV)
-Intolerance to previous DDAVP administrations
-DDAVP not advisable due to type of surgery or bleeding according to the hematologist and/or surgeon
-Start of FVIII-concentrate treatments >24 hours ago

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main endpoint will be the proportion of patients within FVIII target levels with DDAVP and FVIII concentrate combination treatment in the first 72 hours after surgery, without adding off-protocol FVIII concentrates

Secondary Outcome Measures

Name	Time	Method
-A population based pharmacokinetic model<br /><br>-Number and nature of adverse events during combined treatment<br /><br>-Incidence & severity of bleeding <br /><br>-Incidence of thrombosis <br /><br>-Incidence and extent of tachyphylaxis<br /><br>-Economical evaluation<br /><br>-Experienced quality of care<br>