NCT03408379

Brief Summary

Sub arachnoid hemorrhage consecutive to intracranial aneurysm rupture is a devastating disease. Predictors of intracranial aneurysm rupture are limited and focus mainly on size and location. Platelet activation may have a deleterious role on aneurysm rupture. The assumption is that patients with ruptured intracranial aneurysm will present a higher rate of platelet activation compared to patients with non ruptured aneurysms.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
87mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress54%
Dec 2017Jun 2033

Study Start

First participant enrolled

December 20, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2032

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2033

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

14.5 years

First QC Date

January 17, 2018

Last Update Submit

January 16, 2026

Conditions

Keywords

intracranial aneurysmsruptured aneurysmplatelet activity

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with platelet activation

    comparison of this proportion between patients with ruptured versus non ruptured intracranial aneurysm

    in the 7 days before embolisation

Interventions

In case of an endovascular treatment : * A blood sample (venous or arterial) of 10 ml will be taken at the beginning of the procedure, an intra aneurysmal blood sample (1mL) will be taken during the procedure and a blood sample (arterial) of 1 mL will be taken at the end of the procedure. * Iterative blood samples (arterial) of 10 mL will be taken at each follow up visit. In case of a surgery treatment : * A blood sample (venous or arterial) of 10 ml will be taken at the beginning of the surgery. * A Tissue sample will be taken during the surgery * Iterative blood samples (arterial) of 10 mL will be taken at each follow up visit.

Eligibility Criteria

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

Adult patients presenting a single or multiple intracranial aneurysm for which an intervention is planned (endovascular treatment or surgery)

You may qualify if:

  • Patient aged 18 and over
  • Patient presenting a single or multiple aneurysm
  • Patient presenting an intracranial aneurysm for which an intervention is planned (endovascular treatment or surgery) : elective intervention for an unruptured aneurysm or emergency surgery for a broken aneurysm

You may not qualify if:

  • Pregnant or breast feeding woman
  • Patient benefiting from legal protection measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, France, 75019, France

Location

MeSH Terms

Conditions

Intracranial AneurysmAneurysm, Ruptured

Interventions

Vasodilation

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 24, 2018

Study Start

December 20, 2017

Primary Completion (Estimated)

June 23, 2032

Study Completion (Estimated)

June 23, 2033

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations