Subarachnoid Hemorrhage, Aneurysmal Clinical Trial
— RESCUE-SAHOfficial title:
The Effect of Remote Ischemic Conditioning on Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage: A Prospective, Randomized, Patient-assessor Blinded, Sham-controlled Pilot Study Investigating Effect on Clinical Outcome.
The goal of this clinical trial is to examine the effect of limb occlusion therapy (remote ischemic conditioning, RIC) in subjects with aneurysmal subarachnoid hemorrhage. The main question it aims to answer is whether RIC can improve long-term recovery in participants with aneurysmal subarachnoid hemorrhage. Researchers will compare levels of functional independence in participants in the RIC-group to participants in the sham-group.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 30, 2027 |
Est. primary completion date | November 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aneurysmal subarachnoid hemorrhage confirmed by computed tomography (CT) with aneurysm origin confirmed by computed tomography angiography (CTA) or digital subtraction angiography (DSA) - Aneurysmal subarachnoid hemorrhage symptom-onset = 3 days - Aneurysm protected by clipping or coiling - Independent in daily living before symptom onset (mRS = 2) Exclusion Criteria: - Subarachnoid hemorrhage caused by a lesion other than cerebral aneurysm - Symptomatic vasospasm at the time of enrollment - Previous cerebral lesion e.g. symptomatic cerebral infarction (>2cm), multiple sclerosis, symptomatic intracerebral hemorrhage, tumour, prior neurosurgery (excluding prior clipping or coiling of cold aneurysms without complications). - History of severe peripheral vascular disease or signs of severe peripheral vascular disease on physical examination - History of deep vein thrombosis or signs of deep vein thrombosis on physical examination - Kidney involvement or prior kidney disease with an estimated glomerular filtration rate (eGFR) below safe levels for contrast infusion in relation to CT-perfusion. - Pregnancy (Women of child-bearing age will have serum-Humane Choriogonadotropine taken prior to final inclusion. If pregnancy cannot be ruled out,the patient can't be included. Women with a safe birth control method will be encouraged to use this method during the entire period of active treatment.) - Concomitant other acute life-threatening medical or surgical condition |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neurosurgery, Aarhus University Hospital | Aarhus N | Danmark |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Gonzalez NR, Connolly M, Dusick JR, Bhakta H, Vespa P. Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage. Neurosurgery. 2014 Nov;75(5):590-8; discussion 598. doi: 10.1227/NEU.0000000000000514. — View Citation
Hess DC, Blauenfeldt RA, Andersen G, Hougaard KD, Hoda MN, Ding Y, Ji X. Remote ischaemic conditioning-a new paradigm of self-protection in the brain. Nat Rev Neurol. 2015 Dec;11(12):698-710. doi: 10.1038/nrneurol.2015.223. Epub 2015 Nov 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical outcome after 6 months measured by modified Rankin scale score (0-6, Higher score indicates worse outcome) | Assessed by telephone interview. Patient assessor is blinded to intervention | Assessed 6 months after initial aneurysm rupture. | |
Secondary | Difference in Infarct growth | Assessed by MRI, measured by segmentation and calculation of infarct volume. | MRI performed 4-6 weeks after initial hemorrhage. | |
Secondary | Clinical outcome after 14 days measured by modified Rankin scale score (0-6, Higher score indicates worse outcome) | Assessed by clinician in charge of patient discharge. | 14 days after initial hemorrhage. | |
Secondary | Occurrence of delayed cerebral ischemia | Neurological deterioration after aSAH where DCI is deemed most likely cause, supported by angiography/perfusion CT. | Within first 14 days after initial hemorrhage. | |
Secondary | Mortality after 3 months | Assessed via patient records. Assessor is blinded to intervention. | Assessed at 3 months post initial hemorrhage | |
Secondary | Mortality after 12 months | Assessed via patient records. Assessor is blinded to the intervention. | Assessed at 12 months post initial hemorrhage | |
Secondary | Presence of angiographic vasospasm on CT angiography baseline vs 8-day scan | Evaluated by a neuro-radiologist with more than 10 years of experience in intracerebral angiography. Assessor is blinded to intervention. | 8-9 days post initial hemorrhage. |
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