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OpenTrials
Completed

NCT Number: NCT02893631

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

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. fibrinolysis activity

    Time frame: until normalization of fibrinolytic activity, up to 48 hours

    Time required for normalization of fibrinolysis

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: HEMOLYSE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2016
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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