Impact of Emicizumab on Activated Clotting Time Using the i-STAT Alinity Analyzer

Recruiting

• Conditions: Hemophilia A
• Interventions: Diagnostic Test: ACT

• Registration Number: NCT05856903
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Emicizumab (Hemlibra®) is a subcutaneous hemostatic treatment approved in 2019 for the prophylaxis in severe hemophilia A. Emicizumab is a bispecific monoclonal antibody mimicking factor VIIIa that provides a constant level of coagulation similar to that observed in minor haemophilia A patients whose factor VIII level is 10-15%. Although the correction of plasma coagulation in vivo is only partial, emicizumab strongly shortens the in vitro coagulation times involving the intrinsic pathway such as aPTT(activated partial thromboplastin time).

The investigators will evaluate the effect of emicizumab on a coagulation test (Activating clotting time (ACT i-STAT Alinity)) used as a point of care device to monitor heparin therapies during cardiac surgeries (cardiopulmonary bypass) and cardiac catheterizations. Because ACT is activated through the intrinsic pathway, it may also be shortened by emicizumab. Prophylactic treatment with emicizumab would make it impossible to use ACT for heparin therapy in a hemophiliac patient benefiting from this treatment.

The aim of this in vitro study is to assess the effect of emicizumab on the in vitro heparin-induced ACT increase in severe hemophilia A patients treated with emicizumab and in healthy volunteers (measurement on the i- STAT Alinity) thanks to in vitro blood spiking experiments.

Some data have already been published with other ACT devices (Hemochron..) but never with the i-STAT Alinity device which uses a different technology and other reagents.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-12
• Status Verified: 2023-07
• Study Start: 2023-07-12
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

• infusion of factor VIII < 5 days
• patients refusing to participate in the study
• protected persons
• anticoagulants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe hemophiliac patients under emicizumab	ACT	-
Healthy volunteers	ACT	-

Primary Outcome Measures

Name	Time	Method
Modification of ACT by emicizumab	Day 0	Modification of the in vitro heparin-induced ACT increase by emicizumab

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, France