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Trial record 23 of 195 for:    Hemorrhage AND SAH

Remote Ischemic Pre-conditioning in Subarachnoid Hemorrhage (RIPC-SAH)

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ClinicalTrials.gov Identifier: NCT02381522
Recruitment Status : Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ronak Raval, Loma Linda University

Brief Summary:

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
Brain Aneurysms Other: Remote Ischemic Pre-conditioning Other: Sham RIPC Not Applicable

  Show Detailed Description

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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
Study Start Date : March 2015
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.
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.
Other: Sham RIPC



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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
Criteria

Inclusion Criteria:

  1. > 18 years of age
  2. 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


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): NCT02381522


Locations
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United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Ronak Raval, MD Loma Linda University

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Responsible Party: Ronak Raval, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT02381522     History of Changes
Other Study ID Numbers: 5150015
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Ronak Raval, Loma Linda University:
remote ischemic preconditioning
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Intracranial Aneurysm
Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases