Trial record 4 of 136 for:    "COL4A1-related brain small-vessel disease" OR "Cerebral Hemorrhage"

Targeted Temperature Management After Intracerebral Hemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01866384
First received: May 20, 2013
Last updated: June 3, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01866384     History of Changes
Other Study ID Numbers: 12D.466
Study First Received: May 20, 2013
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014