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NCT03408379 Clinical Trial

Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN

Intracranial Aneurysms Clinical Trial

— PLAQRAN  

Official title:
Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03408379
Other study ID # MMI_2017_27
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 20, 2017
Est. completion date August 2028

Study information
Verified date July 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 230
Est. completion date August 2028
Est. primary completion date December 20, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Pregnant or breast feeding woman

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Collection of blood sample in aneurysm
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.

Locations
Country Name City State
France Fondation Ophtalmologique A. de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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