MedTrace Logo

REperfusion With Cooling in CerebraL Acute IscheMia II

NCT02411877 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-02-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients who have undergone hypothermia to those who have not.

Conditions

Interventions

PROCEDURE

Normothermia

Device: Trevo Pro Retriever (Stryker Corp.)

PROCEDURE

Mild hypothermia

Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)

DEVICE

Trevo Pro Retriever (Stryker Corp.)

Device: Trevo Pro Retriever (Stryker Corp.)

DEVICE

Zoll Thermogard XP technology with the Quattro catheter

Device: Zoll Thermogard XP technology with the Quattro catheter

Sponsors & Collaborators

  • Zoll Medical Corporation

    collaborator INDUSTRY

  • WellStar Health System

    lead OTHER

Principal Investigators

  • Rishi Gupta, MD · WellStar Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02411877 on ClinicalTrials.gov