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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26618

Enrollment

Registered

2016-09-16

Start date

2016-11-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Interventions

Desmopressin and FVIII concentrate combination treatment.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Efficacy of treatment, measured as the deviation of the measured FVIII from the predicted FVIII range preoperatively. The amount of FVIII concentrate in IU per kilogram	—

Secondary

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

Measure

Time frame

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

—

Contacts

Public ContactL.G.R. Romano

Erasmus MC - room Na-823

DAVID@erasmusmc.nl+3110-70435

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)