NCT03268668

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

77
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2017Jan 2028

Study Start

First participant enrolled

July 13, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

10 years

First QC Date

August 29, 2017

Last Update Submit

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

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

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

RECRUITING

CHU Caen

Caen, 14000, France

RECRUITING

Chu Limoges

Limoges, 87000, France

RECRUITING

CHRU de Nancy

Nancy, 54000, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

Hôpital Lariboisière AP-HP

Paris, 75010, France

RECRUITING

Centre hospitalier Sainte-Anne

Paris, 75014, France

RECRUITING

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

RECRUITING

CHU de Rennes

Rennes, 35000, France

COMPLETED

Hôpital Foch

Suresnes, 92150, France

RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83000, France

RECRUITING

CHRU Tours

Tours, 37000, France

RECRUITING

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.

MeSH Terms

Conditions

Stroke

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Philippe Désilles, MD

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Yavchitz, MD PhD

CONTACT

Jean-Philippe Désilles, MD

CONTACT

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

Locations