Clinical Trials Logo

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.


Clinical Trial 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. ;


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


NCT number NCT01607151
Study type Interventional
Source Thomas Jefferson University
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date January 2013
Completion date June 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05089331 - ROSE-Longitudinal Assessment With Neuroimaging
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT04522102 - Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase Phase 3
Terminated NCT04178746 - PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
Not yet recruiting NCT03956485 - Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).
Enrolling by invitation NCT02920645 - Multicenter Validation of the AVICH Score N/A
Recruiting NCT02625948 - Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign Phase 2
Completed NCT02478177 - Addressing Real-world Anticoagulant Management Issues in Stroke
Completed NCT01971359 - Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study N/A
Terminated NCT00990509 - Albumin for Intracerebral Hemorrhage Intervention Phase 2
Completed NCT01261091 - Early Tracheostomy in Ventilated Stroke Patients N/A
Completed NCT00716079 - The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial N/A
Recruiting NCT00222625 - rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets Phase 2
Recruiting NCT05095857 - The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury Phase 4
Recruiting NCT04548596 - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Not yet recruiting NCT06429332 - International Care Bundle Evaluation in Cerebral Hemorrhage Research Phase 4
Recruiting NCT05492474 - Cranial Ultrasound for Prehospital ICH Diagnosis N/A
Not yet recruiting NCT05502874 - Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
Recruiting NCT04604587 - MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA Phase 3
Recruiting NCT05504941 - Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage N/A