Recent Updates
Recently added Catalysts

Induced Hypothermia

Phase 2

Traumatic Brain Injury | Unknown | Neurology |Pulmonx Corporation|Last Updated: Jun 22, 2010

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Induced Hypothermia · 1 trial · 1 indication

Phase 2 1
NCT00282269Hypothermia in Traumatic Brain Injury in Children (HiTBIC)Traumatic Brain Injury
COMPLETED50 Analytics
PHASE2COMPLETED
Hypothermia in Traumatic Brain Injury in Children (HiTBIC)
Traumatic Brain InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

Paediatric Cerebral Performance Category (PCPC) at 12 months after injury
12 months
Recruitment Rates
Recruitment completion
Adverse Events
Recruitment completion

Secondary Endpoints

Intracranial pressure(ICP)/Cerebral perfusion pressure(CPP) control
Recruitment completion
Duration of mechanical ventilation
Recruitment completion
Intensive care and hospital length of stay
Recruitment completion
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Induced HypothermiaPROCEDUREInduced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours
Unlock Study Design Details

Eligibility Criteria

Age Range1 Year to 16 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * have a severe traumatic brain injury as defined by either a GCS ≤ 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score ≤ 3 and normal CT scan * are aged between 1 and 16 years * are mechanically ventilated Exclusion Cri...

Countries:AustraliaNew Zealand
Unlock Eligibility Criteria

Frequently asked questions about Induced Hypothermia

What is Induced Hypothermia used for in Traumatic Brain Injury?

Induced Hypothermia is being studied for the treatment of Traumatic Brain Injury. It is an investigational therapy currently in Phase 2 clinical development. The approach involves lowering body temperature to potentially reduce brain damage following injury. It is not yet approved by regulatory authorities and remains under investigation.

Who is developing Induced Hypothermia?

Pulmonx Corporation (NASDAQ: LUNG) is the developer of Induced Hypothermia for Traumatic Brain Injury. The company is conducting clinical research to evaluate the safety and efficacy of this therapy in patients with this condition.

What phase is Induced Hypothermia in?

Induced Hypothermia is in Phase 2 clinical development for Traumatic Brain Injury. It is an investigational therapy, meaning it has not been approved by regulatory agencies. A Phase 2 clinical trial has been completed to assess its effects in the target patient population.

What clinical trials is Induced Hypothermia in?

Induced Hypothermia has been evaluated in one completed Phase 2 clinical trial, NCT00282269, titled "Hypothermia in Traumatic Brain Injury in Children (HiTBIC)." This study enrolled 50 participants with Traumatic Brain Injury and was conducted in Australia and New Zealand.

Is Induced Hypothermia the same as therapeutic hypothermia?

Induced Hypothermia refers to the deliberate lowering of body temperature for therapeutic purposes. In the context of Traumatic Brain Injury, it is being investigated as a neuroprotective strategy. The clinical trial NCT00282269 specifically studied this approach in children with the condition.