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Remote Ischemic PreConditioning (RIPC)

NCT03814850 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-08

No results posted yet for this study

Summary

The purpose of this study is to learn about protecting the brain from low blood flow (ischemia) with limb preconditioning. From human studies the investigators know that the brain can be protected from dangerous low blood flow by reducing the blood flow to an arm or leg for just a short period of time. This is called limb preconditioning. The investigators are studying the safety and feasibility of preconditioning and their effect of protecting the brain from ischemia in two different groups. This is a Phase 2, randomized, double-blind, sham-controlled, design. Up to 50 male and female patients undergoing elective endovascular repair of unruptured brain aneurysm who are randomized to the remote ischemic preconditioned or sham group will be enrolled. This study consists of one 3-9 month study period for each patient plus up to 14 days for enrollment activities. Subjects are required to return between 3-9 months for end-of-study procedures.

Conditions

  • Unruptured Cerebral Aneurysm

Interventions

DEVICE

Standard Manual Aneroid Sphygmomanometer

Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.

Sponsors & Collaborators

  • Sebastian Koch

    lead OTHER

Principal Investigators

  • Robert Starke, M.D. · University of Miami

  • Sebastian Koch, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03814850 on ClinicalTrials.gov