Safety and Feasibility Study of Targeted Temperature Management After ICH

NCT01607151 | Unknown Phase 1 DMC

• 1 other identifier: 12CRP12050342
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hypothermia; normothermia; hyperthermia

Outcome Measures

Primary Outcomes (1)

• Severe adverse events (SAEs)

  The primary outcome measures will be: a) the frequency of adverse events (AEs) that will be possibly or probably related to treatment. AEs will be assessed up to 15-days after admission or discharge if earlier, and b) the frequency of severe adverse events (SAEs) that will be possibly and probably related to treatment.

  90 days

Secondary Outcomes (4)

• In-hospital neurological deterioration between day 0-7

  7 days

• Functional outcome

  Discharge and 90 days

• Hematoma growth

  24 hours

• Cerebral edema

  24, 48,72, and 168-hours

Study Arms (2)

Normothermia

ACTIVE COMPARATOR

Core temperature 36-37 C

Other: Normothermia

Hypothermia

EXPERIMENTAL

Core temperature 32-34 C

Other: Hypothermia

Interventions

Normothermia OTHER

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

Normothermia

Hypothermia OTHER

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

Hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spontaneous supratentorial ICH documented by CT scan within 18 hours after the onset of symptoms
• Admission to the Neuro-ICU
• Baseline hematoma \>15cc with or without IVH
• Need for mechanical ventilation.

You may not qualify if:

• GCS \<6
• Age \<18 years
• Pregnancy
• Pre-morbid modified Rankin Scale (mRS) \>2
• Do Not Resuscitate (DNR) order "prior" to enrollment
• Uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding \[UGIB/LGIB\])
• Planned surgical decompression within 24 hours
• Secondary causes of ICH (ischemic stroke, coagulopathy \[INR\>1.4, aPTT\> 1.5 times baseline, thrombocytopenia platelets \<100,000/uL\], trauma, AVM, aneurysm, cerebral sinus thrombosis, or other causes)
• Evidence of sepsis
• Spontaneous hypothermia (core Temperature \<36C)
• Inability to obtain written informed consent
• Participation in another trial.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• American Heart Association: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Hypothermia; Hyperthermia

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Fred Rincon, MD, MSc

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

US (1)