Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

NCT02902393 | Unknown

• 1 other identifier: 15-202
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy. The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.

Conditions

Stroke

Keywords

Fibrinolysis; tPA

Outcome Measures

Primary Outcomes (1)

• Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI

  24 hours

Secondary Outcomes (1)

• Clinical evaluation using NIHSS scale

  24 hours

Study Arms (1)

Success of revascularisation

Biological: Thromboelastography

Interventions

Thromboelastography BIOLOGICAL

Success of revascularisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients meeting the eligibility criteria will be invited to participate in the study . Patients will be recruited to emergencies CHU Caen and Saint Joseph Hospital. The goal is to recruit patients with neurological defect consistent with a neurovascular pathology eligible for thrombolysis with tPA. With the admission of patients, blood samples are routinely made . For this study, the investigators will add one citrated 5 mL tube. An information letter and consent form will be given to the patient.

You may qualify if:

• Patient (\> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).

You may not qualify if:

• Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital

Caen, Calvados, 14000, France

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Richard MACREZ, PhD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yohann REPESSE, MD PhD

CONTACT

+330231063315; repesse-y@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 15, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

FR (1)