Peri-Operative PharmacokineTIc-guided dosing of CLOTting factor in Hemophilia

Completed

• Conditions: hemofilie A, operatie, behandeling, farmacokinetisch-gedoseerd, farmacokinetiek, kostenverlaging; Hemophilia A, surgery, treatment, pharmacokinetic-guided, pharmacokinetics, costreduction

• Registration Number: NL-OMON29652
• Lead Sponsor: Erasmus University Medical Center Rotterdam, Sophia Childrens Hospital

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total amount of infused FVIII concentrate (IU) per kilogram body weight during the peri-operative period per post-operative day (from 72 hours before surgery up to 14 days after surgery).

Secondary Outcome Measures

Name	Time	Method
1. Peri-operative hemostasis as quantified by hemoglobin values pre- and postoperatively, blood loss and classification of blood loss as compared to expected blood loss in a hematologically healthy individual with that specific surgical procedure. <br /><br>2. Achieved FVIII levels after recombinant FVIII infusion (IU ml-1).<br /><br>3. Length of hospitalization (days).<br /><br>4. Effect of baseline VWF antigen, VWF propeptide values and blood type on FVIII clearance.<br /><br>5. Economic evaluation.