Stroke, Acute Clinical Trial
— HEMOLYSEOfficial title:
Assessment of Hemostasis Disorders in Tissue Plasminogen Activator Treated (rtPA-treated) Patients Requiring Endovascular Treatment for Ischemic Stroke
NCT number | NCT02893631 |
Other study ID # | AGR_2015_25 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | October 2019 |
Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery
occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis
induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of
these effects are unknown. Thus management of antithrombotics and hemostasis during
thrombectomy and surgery is an issue.
Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis,
coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to
evaluate the time required for the normalization of these disorders.
Methods : Observational monocentric study including rtPA-treated patients requiring
endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA
administration to assess of fibrinolysis, coagulation and platelet functions with point of
care devices and specific laboratory tests. Record of clinical and biological data.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | October 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patient over 18 - treatment with rtPA for an acute stroke - endovascular treatment required Exclusion Criteria: - opposition to participate in the study - long term anticoagulant-treated patient - pregnant patient |
Country | Name | City | State |
---|---|---|---|
France | Fondation Ophtalmologique Adolphe de Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fibrinolysis activity | Time required for normalization of fibrinolysis | until normalization of fibrinolytic activity, up to 48 hours |
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