We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Targeted Temperature Management After Intracerebral Hemorrhage

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Thomas Jefferson University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866384
First Posted: May 31, 2013
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University
  Purpose
Early hematoma growth (HG) after spontaneous intra-cerebral/intra-parenchymal hemorrhage (IPH) is common and associated with neurological deterioration and poor clinical outcome. Temperature modulation to hypothermia (Temperature, 32-34°C) has been associated with reduction or improvement of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. In this sense, we believe that the initiation of an ultra-early protocol of active temperature modulation or Targeted Temperature Management (TTM) to mild induced hypothermia (MIH, 32-34°C) may be associated with good safety and tolerability profile, less HG and cerebral edema after IPH by modulation of systemic and local inflammatory responses, so we hypothesize that TTM to MIH will be a safe/tolerable and effective therapy to limit HG and cerebral edema after IPH.

Condition Intervention Phase
Cerebral Hemorrhage Hypothermia Procedure: mild induced hypothermia Other: Normal Temperature Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Safety and Tolerability of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Frequency of adverse events (AEs) that will be possibly or probably related to the treatment. [ Time Frame: Continuous throughout 3 year study period ]
    To determine whether TTM to MIH is safe and tolerable after IPH measured by the frequency of adverse events (AEs) that will be possibly or probably related to the treatment.


Secondary Outcome Measures:
  • In-hospital neurological deterioration between day 0-7. [ Time Frame: Continuous throughout 3 year study period ]
    To determine whether TTM to MIH can limit hematoma growth and cerebral edema measured by in-hospital neurological deterioration between day 0-7.


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Normal Temperature
72 hours of Normal Temperature (36-37 degrees Celcius). Subjects in all arms will otherwise receive identical therapeutic interventions pre-defined by our local IPH management protocol.
Other: Normal Temperature
In this arm, the patient will have standard of care intraparenchymal hemorrhage management per institutional policy, with normal body temperature management (36-37 degrees Celcius).
Experimental: Mild Induced Hypothermia
72 hours of mild induced hypothermia (32-34 degrees Celcius). Subjects in all arms will otherwise receive identical therapeutic interventions pre-defined by our local IPH management protocol.
Procedure: mild induced hypothermia
Patients with intraparancymal hemorrhage within 6 hours of onset will be randomized to either the mild induced hypothermia group or the normal temperature group (control). In this arm, the patient will have 72 hours of Targeted Temperature Managment to mild induced hypothermia (32-34 degrees Celcius).

Detailed Description:

In this randomized clinical trial, patients with IPH within 6 hours of onset will be randomized to one of two study arms. In one arm, patients will have 72 hours of TTM to MIH (32-34 degree Celcius). In the second arm, patients will have 72 hours of TTM to Normal Temperature (NT)(36-37 degrees Celcius). Subjects in all arms will otherwise receive identical therapeutic interventions pre-defined by our local IPH management protocol.

Primary outcomes are examining 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 the frequency of severe adverse events (SAEs) that will be possibly and probably related to treatment.

SAEs will be assessed up to 90-days.

The secondary outcome measures will be in-hospital neurological deterioration between day 0-7 (decrease in GCS10 in ≥2 points, or increase in the NIHSS11 ≥4 points), in-hospital mortality, modified Rankin Score [mRS]12 at discharge and 90-days.

To determine whether TTM to MIH can limit HG and cerebral edema, will be examining absolute change in hematoma between baseline and 24 hours, new or absolute change in IVH between baseline and 24 hours, the proportion of patients with HG, absolute change in hemostatic proteins, the absolute change in cerebral edema between baseline and 24, 48,72, and 168-hours, relative change in cerebral edema.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • spontaneous supratentorial IPH documented by CT scan within 6 hours after the onset of symptoms and admission to the Neuro-ICU,
  • baseline hematoma >15cc with or without IVH
  • need for mechanical ventilation

Exclusion Criteria:

  • GCS <6
  • age <18 years
  • pregnancy
  • pre-morbid 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 IPH (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
  • inability to obtain written informed consent
  • participation in another trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866384


Contacts
Contact: Jennifer Glendening, MSN, RN 215-955-7962 jennifer.glendening@jefferson.edu
Contact: John Furlong, RN,CCRC 215-955-7301 john.furlong@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Meghan Wakefield, RN,CCRP    215-503-9110    meghan.wakefield@jefferson.edu   
Principal Investigator: Fred Rincon, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Fred Rincon, MD Thomas Jefferson University
  More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01866384     History of Changes
Other Study ID Numbers: 12D.466
First Submitted: May 20, 2013
First Posted: May 31, 2013
Last Update Posted: December 18, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Hypothermia
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases