COMPLETEDNA

Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury

This study is a prospective multi-centre randomized trial to compare the effect of long-term mild hypothermia versus routine normothermic intensive management in patients with severe traumatic brain injury. The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5 days will improve the outcome of patients at six months post injury compared with normothermia.

Sponsor

RenJi Hospital

Enrollment

312 participants

Sites

1 locations

Start Date

November 2013

Completion

June 2019

Brain InjuriesCraniocerebral TraumaLong-term mild hypothermiaNormothermia

Enrollment & Timeline

Completed

Target N

312

participants

Sites

locations

Duration

5.6 years

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 5.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

Neurological function

6 months post injury

The neurological function will be evaluated at 6 months post injury by a specialized investigator who is unaware of the patients' allocation according to five-category Glasgow Outcome Scale as follows: 1, death; 2, vegetative state - unable to interact with the environment; 3, severe disability - unable to live independently but able to follow commands; 4, moderate disability - capable of living independently but unable to return to work or school; and 5, good recovery - able to return to work or school.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Effect of long-term mild hypothermia or short-term mild hypothermia on outcome of patients with severe traumatic brain injury.

Jiang Ji-Yao, Xu Wei, Li Wei-Ping et al.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism2006

DOI PubMed

Rationale, methodology, and implementation of a nationwide multicenter randomized controlled trial of long-term mild hypothermia for severe traumatic brain injury (the LTH-1 trial).

Lei Jin, Gao Guoyi, Mao Qing et al.Contemporary clinical trials2015

DOI PubMed

Safety and efficacy of long-term mild hypothermia for severe traumatic brain injury with refractory intracranial hypertension (LTH-1): A multicenter randomized controlled trial.

Hui Jiyuan, Feng Junfeng, Tu Yue et al.EClinicalMedicine2023

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

COMPLETEDNA

Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury

Sponsor

RenJi Hospital

Enrollment

312 participants

Sites

1 locations

Start Date

November 2013

Completion

June 2019

Brain InjuriesCraniocerebral TraumaLong-term mild hypothermiaNormothermia

Enrollment & Timeline

Completed

Target N

312

participants

Sites

locations

Duration

5.6 years

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 5.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Neurological function

6 months post injury

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Effect of long-term mild hypothermia or short-term mild hypothermia on outcome of patients with severe traumatic brain injury.

Jiang Ji-Yao, Xu Wei, Li Wei-Ping et al.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism2006

DOI PubMed

Rationale, methodology, and implementation of a nationwide multicenter randomized controlled trial of long-term mild hypothermia for severe traumatic brain injury (the LTH-1 trial).

Lei Jin, Gao Guoyi, Mao Qing et al.Contemporary clinical trials2015

DOI PubMed

Safety and efficacy of long-term mild hypothermia for severe traumatic brain injury with refractory intracranial hypertension (LTH-1): A multicenter randomized controlled trial.

Hui Jiyuan, Feng Junfeng, Tu Yue et al.EClinicalMedicine2023

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

all

Healthy Volunteers

View full criteria

Inclusion Criteria:

* Age 18 - 65 years within 6 hours post injury;
* Closed head injury;
* Glasgow Coma Scale(GCS) score 4 to 8 after resuscitation;
* The intracranial pressure is more than 25 mmHg;
* Cerebral contusion on computed tomographic scan.

Exclusion Criteria:

* GCS of 3 with bilateral fixed and dilated pupils;
* A life-threatening injury to an organ other than the brain;
* No spontaneous breathing or cardiac arrest at the scene of the injury;
* No consent;
* Pregnancy.

Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)