NCT01886222

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

November 12, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

5.6 years

First QC Date

June 17, 2013

Last Update Submit

March 10, 2020

Conditions

Brain InjuriesCraniocerebral Trauma

Keywords

Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Neurological function

    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.

    6 months post injury

Secondary Outcomes (6)

  • Intracranial pressure (ICP) control

    Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, or until the monitor is removed

  • Glasgow Coma Score (GCS)

    Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21, day 28 post injury

  • Length of ICU stay

    6 months post injury

  • Length of hospital stay

    6 months post injury

  • Frequency of complications

    6 months post injury

  • +1 more secondary outcomes

Study Arms (2)

Long-term mild hypothermia

EXPERIMENTAL

Focused intervention

Other: Long-term mild hypothermia

Normothermia

OTHER

Standard management

Other: Normothermia

Interventions

Long-term mild hypothermiaOTHER

Hypothermia will be induced within 6 hours of injury and maintained at 34-35℃ for 5 days.Then the patients will be passively rewarmed to a temperature of 36 to 37˚C at a rate no greater than 0.5˚C/4 hours.

Also known as: Mild hypothermia therapy
Long-term mild hypothermia
NormothermiaOTHER

Patients assigned to the normothermia group will be kept at 36-37℃.

Normothermia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (3)

  • Jiang JY, Xu W, Li WP, Gao GY, Bao YH, Liang YM, Luo QZ. Effect of long-term mild hypothermia or short-term mild hypothermia on outcome of patients with severe traumatic brain injury. J Cereb Blood Flow Metab. 2006 Jun;26(6):771-6. doi: 10.1038/sj.jcbfm.9600253.

    PMID: 16306933BACKGROUND

  • Lei J, Gao G, Mao Q, Feng J, Wang L, You W, Jiang J; LTH-1 trial collaborators. 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). Contemp Clin Trials. 2015 Jan;40:9-14. doi: 10.1016/j.cct.2014.11.008. Epub 2014 Nov 12.

    PMID: 25460339BACKGROUND

  • Hui J, Feng J, Tu Y, Zhang W, Zhong C, Liu M, Wang Y, Long L, Chen L, Liu J, Mou C, Qiu B, Huang X, Huang Q, Zhang N, Yang X, Yang C, Li L, Ma R, Wu X, Lei J, Jiang Y, Liu L, Gao G, Jiang J; LTH-1 Trial collaborators. Safety and efficacy of long-term mild hypothermia for severe traumatic brain injury with refractory intracranial hypertension (LTH-1): A multicenter randomized controlled trial. EClinicalMedicine. 2021 Jan 28;32:100732. doi: 10.1016/j.eclinm.2021.100732. eCollection 2021 Feb.

    PMID: 33681741DERIVED

Related Links

MeSH Terms

Conditions

Brain InjuriesCraniocerebral TraumaBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jiyao Jiang, MD, PhD

    Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 25, 2013

Study Start

November 12, 2013

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

CN(1)