Status:
COMPLETED
Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Aneurysmal Subarachnoid Haemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral...
Detailed Description
We hypothesize that an early irreversible microvascular deterioration following initial bleeding could contribute to DCI occurrence. More precisely, we suspect that DCI areas are somehow overlaps of r...
Eligibility Criteria
Inclusion
- written informed consent to participate in the study must be obtained from the subject or proxy/legal representative prior to enrollment.
- males and females aged 18 years and older.
- SAH proven by computed tomography (CT) and that has occurred within the last 72 hours.
- ruptured saccular aneurysm angiographically confirmed by digital subtraction angiogram or CT angiogram, which has been successfully secured by surgical clipping or endovascular coiling.
- high-risk subjects for DCI: "thick clot" on the hospital admission CT (grade 3 or grade 4 on the modified Fisher Scale).
- a woman of childbearing potential is eligible only if the serum pregnancy test performed during the screening period is negative.
Exclusion
- PET/CT contradications
- MRI contradications
- gadolinium or meglumine hypersensitivity
- glomerular filtration rate \<30mL/min
- SAH due to other causes than ruptured saccular aneurysm.
- post-HSA cardiac arrest.
- high sustained ICP ( \>20mmHg lasting \>20min) despite optimal treatment.
- significant and concomitant organ failure amongst the following: hypotension with systolic blood pressure \<90mmHg refractory to treatment; unresolved pulmonary edema or pneumonia with severe hypoxia defined as PaO2/FiO2 \<150; severe cardiac failure requiring inotropic support.
- patients with "do-not-resuscitate" orders, withdrawal of care situation, dying patient.
- vulnerable patient populations (minor, legal vulnerability, prisoner)
- pregnant and nursing mothers.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04356599
Start Date
July 22 2020
End Date
February 19 2024
Last Update
May 31 2024
Active Locations (1)
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1
Département d'Anesthésie-Réanimation Gui de Chauliac 80 Av Augustin.Fliche
Montpellier, France, 34295