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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02902393
Acronym
ROTEMPredict
Enrollment
64
Registered
2016-09-15
Start date
2016-07-31
Completion date
2018-09-30
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Fibrinolysis, tPA

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.

Interventions

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI24 hours

Secondary

MeasureTime frame
Clinical evaluation using NIHSS scale24 hours

Countries

France

Contacts

Primary ContactYohann REPESSE, MD PhD
repesse-y@chu-caen.fr+330231063315

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026