Safety and Feasibility Study of Targeted Temperature Management After ICH

Intracerebral Hemorrhage Clinical Trial

— TTM-ICH  

Official title:

Safety and Feasibility of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01607151
• Other study ID #: 12CRP12050342
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: May 24, 2012
• Last updated: August 4, 2015
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Morbidity and mortality from intra-cerebral/intra-parenchymal hemorrhage (ICH/IPH) are important public health problems. As the most common etiology of ICH/IPH is hypertension, this places a large proportion of the population at risk. In 2011 The American Heart Association (AHA) estimated that in the US, there were 610,000 new stroke cases of which 10% were ICHs, and many required long-term health care. ICH/IPH is associated with the highest morbidity and mortality and only 20% of patients regain functional independence. Temperature modulation to hypothermia (T, 32-34°C) has been associated with modulation of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. Currently, there are no therapies to specifically target ICH/IPH. To this end, novel strategies that go beyond control of glucose, blood pressure, and intra-cranial pressure, aimed at reducing the enlargement of the hematoma and "swelling" surrounding it, could be "the new frontier in the management of ICH/IPH". Since the early resuscitation phase in the Neuro-ICU represents the greatest opportunity for impact on clinical outcome after ICH/IPH, it also appears to be the most promising window of opportunity to demonstrate a benefit when investigating novel therapies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Other:
• Normothermia
72 hours of targeted temperature management to achieve normothermia (36-37°C)
• Hypothermia
72 hours of targeted temperature management to achieve hypothermia (32-34°C)

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	In-hospital neurological deterioration between day 0-7	Decrease in GCS in =2 points or increase in the NIHSS =4 points	7 days	Yes
Secondary	Functional outcome	Modified Rankin Scale at discharge and 90-days.	Discharge and 90 days	Yes
Secondary	Hematoma growth	Absolute change in hematoma between baseline and 24 hours CT-scan and new or absolute change in IVH between baseline and 24 hours CT-scan	24 hours	Yes
Secondary	Cerebral edema	The absolute change in cerebral edema and the relative change in cerebral edema (absolute edema/absolute ICH volume unit less ratio)	24, 48,72, and 168-hours	Yes