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Safety and Feasibility Study of Targeted Temperature Management After ICH

NCT01607151 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-08-05

No results posted yet for this study

Summary

Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited experience with the use of TTM after intracerebral hemorrhage (ICH), the most devastating type of stroke. TTM may be a an intervention to improve patient outcomes. This trial addresses the safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may be the basis for future larger clinical trials.

Conditions

  • Intracerebral Hemorrhage

Interventions

OTHER

Normothermia

72 hours of targeted temperature management to achieve normothermia (36-37°C)

OTHER

Hypothermia

72 hours of targeted temperature management to achieve hypothermia (32-34°C)

Sponsors & Collaborators

Principal Investigators

  • Fred Rincon, MD, MSc · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01607151 on ClinicalTrials.gov