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

Impact of Emicizumab on ACT (Activated Clotting Time) Using the i-STAT Alinity Analyzer: In Vitro Study in Severe Hemophiliacs A and Healthy Volunteers

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05856903
Acronym
EMISTAT
Enrollment
15
Registered
2023-05-12
Start date
2023-07-12
Completion date
2025-03-31
Last updated
2023-08-01

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

Conditions

Hemophilia A

Keywords

Activated Clotting Time, Hemophilia, Emicizumab

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.

Interventions

DIAGNOSTIC_TESTACT

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

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* severe hemophiliacs under emicizumab ( \> 4 weeks)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Modification of ACT by emicizumabDay 0Modification of the in vitro heparin-induced ACT increase by emicizumab

Countries

France

Contacts

Primary ContactRaphaël MARLU, MD
rmarlu@chu-grenoble.fr33476765487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026