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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02893631
Other study ID # AGR_2015_25
Secondary ID
Status Recruiting
Phase N/A
First received August 31, 2016
Last updated February 3, 2017
Start date September 2015
Est. completion date March 2018

Study information

Verified date February 2017
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Laurence SALOMON, MD, PhD
Phone 0033148036431
Email lsalomon@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 2018
Est. primary completion date March 2018
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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

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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