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A Randomized, Multicenter and Controlled Study to Evaluate the Efficacy of Controlled Decompression technique for Severe Traumatic Brain Injury (2 phase)

A Randomized, Multicenter and Controlled Study to Evaluate the Efficacy of Controlled Decompression technique for Severe Traumatic Brain Injury (2 phase)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016909
Enrollment
Unknown
Registered
2018-07-02
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-07-09

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

Conditions

Severe Traumatic Brain Injury

Interventions

Sponsors

Department of Neurosurgery, 101th Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years old male or female 2. sTBI(GCS3-8 points) patients and need craniotomy; 3. patients family members agree to ICP monitoring and other multiple monitoring; 4. Patients and their families have informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe systemic multiple injuries, main injury site is not in the brain; 2. Serious?underlying diseasespharmacohistory like aspirin maybe change outcome of operation; 3. Give up treatment as money or other factors not clinical condition; 4. Those who cannot complete the study plan; 5. Researchers consider anyone that not suitable for selection, as any reasons; 6. Non informed consent.

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality;3-month GOSE;

Secondary

MeasureTime frame
intraoperative acute encephalitis;postoperative complications;ICP and PI;Concentration of NSE, AQP4, TNF-a, vWF and Catecholamine;

Countries

China

Contacts

Public ContactYuhai Wang

Department of Neurosurgery, 101th Hospital of PLA, China?

wangyuhai67@126.com+86 13771166231

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026