NCT02893631

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

August 31, 2016

Last Update Submit

October 15, 2020

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • fibrinolysis activity

    Time required for normalization of fibrinolysis

    until normalization of fibrinolytic activity, up to 48 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

rtPA-treated patients requiring endovascular treatment for ischemic stroke

You may qualify if:

  • patient over 18
  • treatment with rtPA for an acute stroke
  • endovascular treatment required

You may not qualify if:

  • opposition to participate in the study
  • long term anticoagulant-treated patient
  • pregnant patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marie-Claire NGHE, MD, PhD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 8, 2016

Study Start

September 1, 2015

Primary Completion

November 21, 2017

Study Completion

December 21, 2017

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

FR(1)