Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT (NCT04356599) | Clinical Trial Compass
CompletedNot Applicable
Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT
France35 participantsStarted 2020-07-22
Plain-language 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 glucose uptake reflecting microperfusion.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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)
* pr…
What they're measuring
1
Quantification of K1 parameter.
Timeframe: Day 2 +/- 1 day after the initial bleeding
2
Quantification of Ki parameter.
Timeframe: Day 2 +/- 1 day after the initial bleeding