Recruiting
Phase 2

Targeted Temperature Management

Sponsor:

Thomas Jefferson University

Code:

NCT01866384

Conditions

Cerebral Hemorrhage

Hypothermia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mild induced hypothermia

Normal Temperature

Study Details

Brief summary:

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.

Conditions

Cerebral Hemorrhage

Hypothermia

Study ID

NCT01866384

Start date

Sep, 2012

Status verified date

Dec, 2014

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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.

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.

Interventions

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).

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).

Primary outcome measure

  • Frequency of adverse events (AEs) that will be possibly or probably related to the treatment. [ Time Frame: Continuous throughout 3 year study period ]

Central Contacts and Locations

Central contacts

Jennifer Glendening, MSN, RN

215-955-7962jennifer.glendening@jefferson.edu

John Furlong, RN,CCRC

215-955-7301john.furlong@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Meghan Wakefield, RN,CCRP

215-503-9110meghan.wakefield@jefferson.edu

Principal Investigator:

Fred Rincon, MD

More Information

Sponsor

Thomas Jefferson University

Last update posted

Dec 18, 2014

Last verified

Dec, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2014-12-18.