Remote Ischemic Pre-conditioning in Subarachnoid Hemorrhage (RIPC-SAH)
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ClinicalTrials.gov Identifier: NCT02381522 |
Recruitment Status :
Completed
First Posted : March 6, 2015
Last Update Posted : October 29, 2021
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The purpose of the study is to investigate if briefly stopping blood flow to the patient's leg will lead to the patient's body being better able to tolerate possible decreased blood flow to regions of the brain which otherwise frequently happens after subarachnoid hemorrhage.
Previous studies show that various organs such as the heart, brain or kidney can tolerate longer periods of decreased blood flow if prior to that insult shorter periods of decreased blood flow were experienced.
Condition or disease | Intervention/treatment | Phase |
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Brain Aneurysms | Other: Remote Ischemic Pre-conditioning Other: Sham RIPC | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Remote Ischemic Pre-conditioning in Subarachnoid Hemorrhage |
Actual Study Start Date : | March 1, 2015 |
Actual Primary Completion Date : | December 20, 2017 |
Actual Study Completion Date : | December 20, 2017 |
Arm | Intervention/treatment |
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Active Comparator: Remote Ischemic Pre-conditioning
Remote Ischemic Pre-conditioning group will receive 4 cycles of lower extremity occlusion of perfusion by blood pressure cuff inflated to 20 mmHg higher than systolic and confirmed by doppler.
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Other: Remote Ischemic Pre-conditioning |
Sham Comparator: Sham RIPC
Sham procedure group will receive 4 cycles of inflation of lower extremity blood pressure cuff but it will be 20mmhg lower than systolic BP and hence not occlude the vessel.
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Other: Sham RIPC |
- Remote Ischemic Pre-Conditioning's effect on cerebral vasospasm as measured by Transcrananial Doppler (TCD) velocities. [ Time Frame: 2 years ]RIPC or Sham RIPC will be done for two weeks or duration of patients hospital stay if shorter than 2 weeks. TCD measurements will be done during that time.
- Remote Ischemic Pre-conditioning's effect on functional outcome measured by Rankin Score [ Time Frame: 2 years ]Rankin score will be assessed at 2 weeks, and by phone at one and six months.
- Remote Ischemic Pre-conditioning's effect on complete blood count (CBC) [ Time Frame: 2 years ]RIPC or Sham RIPC will be done for two weeks or duration of patients hospital stay if shorter than 2 weeks. CBC measurements will be done during that time.
- Remote Ischemic Pre-conditioning's effect on basic metabolic panel (BMP) [ Time Frame: 2 years ]RIPC or Sham RIPC will be done for two weeks or duration of patients hospital stay if shorter than 2 weeks. BMP measurements will be done during that time.
- Remote Ischemic Pre-conditioning's effect on coagulation parameters [ Time Frame: 2 years ]RIPC or Sham RIPC will be done for two weeks or duration of patients hospital stay if shorter than 2 weeks. Coagulation parameter measurements will be done during that time.
- Remote Ischemic Pre-conditioning's effect on GCS [ Time Frame: 2 years ]RIPC or Sham RIPC will be done for two weeks or duration of patients hospital stay if shorter than 2 weeks. GCS measurements will be done per ICU protocol during that time and they will be recorded.
- Remote Ischemic Pre-conditioning's effect on mortality [ Time Frame: 2 years ]Total six months of follow up will be done and this will be the time mortality is assessed.
- Remote Ischemic Pre-conditioning's effect on needing additional angiographic intervention [ Time Frame: 2 years ]RIPC or Sham RIPC will be done for two weeks or duration of patients hospital stay if shorter than 2 weeks. Need for additional angiographic intervention during this period will be recorded.
- Remote Ischemic Pre-conditioning's effect on additional neurological events [ Time Frame: 2 years ]Total six months of follow up will be done and additional neurological events during this time period will be recorded.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 18 years of age
- Diagnosis of recent aneurysmal subarachnoid hemorrhage
Exclusion Criteria:
1. Patients with a known history of lower limb vascular disease, lower limb vascular bypass surgery and/or peripheral neuropathy

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): NCT02381522
United States, California | |
Loma Linda University | |
Loma Linda, California, United States, 92354 |
Principal Investigator: | Ronak Raval, MD | Loma Linda University |
Responsible Party: | Ronak Raval, Principal Investigator, Loma Linda University |
ClinicalTrials.gov Identifier: | NCT02381522 |
Other Study ID Numbers: |
5150015 |
First Posted: | March 6, 2015 Key Record Dates |
Last Update Posted: | October 29, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
remote ischemic preconditioning |
Subarachnoid Hemorrhage Intracranial Aneurysm Aneurysm Hemorrhage Pathologic Processes Vascular Diseases Cardiovascular Diseases |
Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Intracranial Arterial Diseases |