Safety and Feasibility Study of Targeted Temperature Management After ICH

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT01607151

Run by

Thomas Jefferson University

People needed

50

Starts

2013-01-01

Expected to finish

2016-06-01

Last updated by the study team

2015-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.