NCT01866384

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

3 years

First QC Date

May 20, 2013

Last Update Submit

December 16, 2014

Conditions

Cerebral HemorrhageHypothermia

Outcome Measures

Primary Outcomes (1)

  • Frequency of adverse events (AEs) that will be possibly or probably related to the treatment.

    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.

    Continuous throughout 3 year study period

Secondary Outcomes (1)

  • In-hospital neurological deterioration between day 0-7.

    Continuous throughout 3 year study period

Study Arms (2)

Normal Temperature

OTHER

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

Mild Induced Hypothermia

EXPERIMENTAL

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

Interventions

mild induced hypothermiaPROCEDURE

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).

Mild Induced Hypothermia
Normal TemperatureOTHER

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).

Normal Temperature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Cerebral HemorrhageHypothermia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and Symptoms

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Fred Rincon, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Glendening, MSN, RN

CONTACT

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

John Furlong, RN,CCRC

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 31, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(1)