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Randomized, Single-blind, Controlled Study to Evaluate the Efficacy of Controlled Decompression during Severe Traumatic Brain Injury Craniotomy

Randomized, Single-blind, Controlled Study to Evaluate the Efficacy of Controlled Decompression during Severe Traumatic Brain Injury Craniotomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TCC-13004002
Enrollment
Unknown
Registered
2013-12-14
Start date
2014-01-01
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

severe traumatci brain injury

Interventions

control group:traditional decompressive measure
study group:Controlled decompressive measure

Sponsors

Department of Neurosurgery, 101th Hospital of PLA, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Adult patients with severe TBI, preoperative Glasgow coma score (GCS) of 3-8 underwent emergency craniectomy for haematoma removal; CT image showed supratentorial hematoma(s) and/or contusions with severe mass effect, press and distortion of the lateral ventricles and basal cistern, volume of haematoma at least 30ml. At least one pupil dilated; Legally authorized representative able to provide informed consent.

Exclusion criteria

Exclusion criteria: Brain swelling caused by anoxia or hypotension with minor intracranial bleeding after injury; Patients with coagulation disorders or a history of aspirin intake and some other organ malfunctions; Extensive multifocal cerebral hematoma; Uncommon injury location like hematoma of brain stem, ventricle,or diastema,etalissulcus of transverse sinus; Cases need for bilateral craniotomy at the beginning; Patients with preoperative GCS 3 and bilateral dilated pupils, showed no better or even worse in the treatment of emergency room, and presented with a attenuate respiration and blood pressure.

Design outcomes

Primary

MeasureTime frame
death rate;

Secondary

MeasureTime frame
incidence rate of intraoperative brain swelling;incidence rate of post traumatic cerebral infarction;incidence rate of delayed hematoma;GOS score in discharge;ADL score 6 month afer operation;

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 22, 2026