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Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN (PLAQRAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03408379
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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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.

Condition or disease Intervention/treatment
Intracranial Aneurysms Ruptured Aneurysm Other: Collection of blood sample in aneurysm

Study Design
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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with platelet activation [ Time Frame: in the 7 days before embolisation ]
    comparison of this proportion between patients with ruptured versus non ruptured intracranial aneurysm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients presenting a single or multiple intracranial aneurysm for which an intervention is planned (endovascular treatment or surgery)
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408379


Contacts
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Contact: Laurence SALOMON, MD PhD 0148036431 ext +33 lsalomon@for.paris
Contact: Mikael MAZIGHI mmazighi@for.paris

Locations
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France
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France, 75019
Contact: Mikael MAZIGHI       mmazighi@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03408379    
Other Study ID Numbers: MMI_2017_27
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
intracranial aneurysms
ruptured aneurysm
platelet activity
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Aneurysm, Ruptured
Rupture
Vascular Diseases
Cardiovascular Diseases
 Wounds and Injuries
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases