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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Ruptured
• Intracranial Aneurysm
• Intracranial Aneurysms
• Rupture
• Ruptured Aneurysm

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