Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke

Stroke, Acute Clinical Trial

— HEMOLYSE  

Official title:

Assessment of Hemostasis Disorders in Tissue Plasminogen Activator Treated (rtPA-treated) Patients Requiring Endovascular Treatment for Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02893631
• Other study ID #: AGR_2015_25
• 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
• 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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

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