Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis
COMPO-CLOT
1 other identifier
observational
1,200
1 country
12
Brief Summary
The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology. The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
12 active sites
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
July 13, 2017
CompletedFirst Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
January 20, 2026
January 1, 2026
10 years
August 29, 2017
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).
Since this is an observational, exploratory study that correlates laboratory data (eg for thrombus: fibrinolytic, pro-oxidant activity, eg for blood: plasma fibrinolysis markers, presence of factor Von Willebrand, etc.) and clinical data (characteristics of the stroke, including the TOAST etiological score, the TICI score (TICI = thrombolysis in cerebral infarction), the NIHSS score, etc.), there is no single primary endpoint. Clinical data will be collected up to 3 months after stroke (Rankin score).
3 months
Interventions
A blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria : A) TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase \> 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis
Eligibility Criteria
Adult patients with ischemic stroke
You may qualify if:
- Patients aged 18 years and older
- Presenting with cerebral infarction following arterial occlusion
- Treated for mechanical thrombectomy (whether performed or not)
- For retrospective patients: thrombus already collected (according to the center's usual practice or for another research project).
You may not qualify if:
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
CHU de Bordeaux
Bordeaux, 33000, France
CHU Caen
Caen, 14000, France
Chu Limoges
Limoges, 87000, France
CHRU de Nancy
Nancy, 54000, France
CHU de Nantes
Nantes, 44093, France
Hôpital Lariboisière AP-HP
Paris, 75010, France
Centre hospitalier Sainte-Anne
Paris, 75014, France
Fondation Ophtalmologique A. de Rothschild
Paris, 75019, France
CHU de Rennes
Rennes, 35000, France
Hôpital Foch
Suresnes, 92150, France
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000, France
CHRU Tours
Tours, 37000, France
Related Publications (1)
Di Meglio L, Desilles JP, Solonomenjanahary M, Labreuche J, Ollivier V, Dupont S, Deschildre C, Maacha MB, Consoli A, Lapergue B, Piotin M, Blanc R, Ho-Tin-Noe B, Mazighi M; compoCLOT study groupdagger. DNA Content in Ischemic Stroke Thrombi Can Help Identify Cardioembolic Strokes Among Strokes of Undetermined Cause. Stroke. 2020 Sep;51(9):2810-2816. doi: 10.1161/STROKEAHA.120.029134. Epub 2020 Aug 19.
PMID: 32811390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe Désilles, MD
Fondation Ophtalmologique A. de Rothschild
Central Study Contacts
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 29, 2017
First Posted
August 31, 2017
Study Start
July 13, 2017
Primary Completion (Estimated)
July 12, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share