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Induced Normal Temperature in severe Traumatic Brain Injury

Induced Normal Temperature in severe Traumatic Brain Injury

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-15007514
Enrollment
Unknown
Registered
2015-11-21
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Interventions

Treatment Group:Temperature Control
Control Group:Routine threapy

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 16-65 years; 2. GCS 3-8; 3. The injury mechanism for closed cerebral trauma; 4. Before entering the group - stable hemodynamics, systolic blood pressure > 110mmHg, diastolic blood pressure> 60 mm Hg, the heart rate 35.5 C; 6. Admission less than 8 hours after injury for conservative treatment patients, admission less than 12 hours for patients undergo surgery; 7. No obvious chest trauma.

Exclusion criteria

Exclusion criteria: 1. Pregnant women; 2. Open brain injury, penetrating injury; 3. GCS3 with bilateral mydriasis without light reflex; 4. The other parts of body trauma AIS score > = 4; 5. Continuous hypoxia (oxygen saturation < 94% and greater than 30 minutes).

Design outcomes

Primary

MeasureTime frame
GOSE (6months);GOSE (3months);

Secondary

MeasureTime frame
MMSE (6months);Barthel Index (6months);ICP;Coagulation status;safety;

Contacts

Public ContactJin HU
15197533@qq.com+86 021 52887732

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026