Skip to content

Protocol for the Study on the Efficacy and Safety of Brain Temperature Regulation in Patients with Severe Traumatic Brain Injury Undergoing Controlled Decompression Surgery: A Prospective, Single-Center, Open-Label, Randomized Controlled Trial

Protocol for the Study on the Efficacy and Safety of Brain Temperature Regulation in Patients with Severe Traumatic Brain Injury Undergoing Controlled Decompression Surgery: A Prospective, Single-Center, Open-Label, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101427
Enrollment
Unknown
Registered
2025-04-24
Start date
2025-04-28
Completion date
Unknown
Last updated
2025-04-28

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

1:Controlled decompression surgery based on brain temperature
2:Controlled decompression surgery

Sponsors

The 904th Hospital of the Joint Logistics Support Force of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 16 - 65 years old, male or female; 2.Intracranial pressure (ICP) and brain temperature probe insertion is chosen to be intraventricular; 3.Patients with severe traumatic brain injury requiring surgical treatment (Glasgow Coma Scale [GCS] score of 3 - 8); 4.Family members who consent to ICP and brain temperature monitoring as well as subsequent multimodal monitoring; 5.The patient and their family members have been provided with an informed consent form and have signed it.

Exclusion criteria

Exclusion criteria: 1.Patients with severe systemic polytrauma, where the primary injury is not located within the brain; 2.Severe underlying medical conditions, or a history of medications such as aspirin that may alter the surgical outcome; 3.Withdrawal of treatment due to financial reasons or other non-clinical circumstances; 4.Poor compliance, inability to complete the trial according to the study protocol; 5.For any reason, the researchers deem the patient unsuitable for inclusion; 6.Failure to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality;3-month Glasgow Outcome Scale-Extended (GOS-E) score; 6-month Glasgow Outcome Scale-Extended (GOS-E) score;

Secondary

MeasureTime frame
Intraoperative brain swelling; Postoperative complications;Cytokines (NSE, vWF, TNF-a, and catecholamines);

Countries

China

Contacts

Public ContactWang Yuhai

The 904th Hospital of the Joint Logistics Support Force of the People's Liberation Army

wangyuhai67@126.com+86 137 7116 6231

Outcome results

None listed

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