NCT02381522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

February 13, 2015

Last Update Submit

October 24, 2021

Conditions

Brain Aneurysms

Keywords

remote ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

  • Remote Ischemic Pre-Conditioning's effect on cerebral vasospasm as measured by Transcrananial Doppler (TCD) velocities.

    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.

    2 years

Secondary Outcomes (8)

  • Remote Ischemic Pre-conditioning's effect on functional outcome measured by Rankin Score

    2 years

  • Remote Ischemic Pre-conditioning's effect on complete blood count (CBC)

    2 years

  • Remote Ischemic Pre-conditioning's effect on basic metabolic panel (BMP)

    2 years

  • Remote Ischemic Pre-conditioning's effect on coagulation parameters

    2 years

  • Remote Ischemic Pre-conditioning's effect on GCS

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Remote Ischemic Pre-conditioning

ACTIVE COMPARATOR

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 RIPC

SHAM COMPARATOR

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

Interventions

Remote Ischemic Pre-conditioningOTHER
Remote Ischemic Pre-conditioning
Sham RIPCOTHER
Sham RIPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years of age
  • Diagnosis of recent aneurysmal subarachnoid hemorrhage

You may not qualify if:

  • \. Patients with a known history of lower limb vascular disease, lower limb vascular bypass surgery and/or peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Ronak Raval, MD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2015

First Posted

March 6, 2015

Study Start

March 1, 2015

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(1)