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

NCT05856903 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

ACT

ACT will be measured : * after in vitro spiking with unfractionated heparin of blood samples from severe hemophilia A patients already treated with emicizumab * after in vitro spiking with unfractionated heparin with or without emicizumab of blood samples from healthy volunteers

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Raphaël MARLU, MD · Grenoble Alpes University Hospital

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-12
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856903 on ClinicalTrials.gov