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Fast Twist Drill to Craniotomy versus Direct Craniotomy for Acute Subdural Hematoma with Herniation: The T2C-ASDH Multicenter Randomized Trial

Fast Twist Drill to Craniotomy versus Direct Craniotomy for Acute Subdural Hematoma with Herniation: The T2C-ASDH Multicenter Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122294
Enrollment
Unknown
Registered
2026-04-11
Start date
2026-04-11
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Acute Subdural Hematoma with Herniation

Interventions

Bridging Group:Emergency bedside rapid puncture drainage bridging craniotomy. Before transporting the patient to the operating room, bedside rapid puncture drainage was performed in the emergency depa
Direct Group:Direct craniotomy for hematoma evacuation. After completing preoperative preparation (endotracheal intubation, establishment of intravenous access, anesthesia induction, etc.) in the emer

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years at randomization; 2.Clinical manifestations meeting the rapid diagnostic criteria for cerebral herniation: progressive deterioration of consciousness and pupillary dilation (GCS =4 mm, absent light reflex); 3.Cranial CT showing acute subdural hematoma with significant mass effect, with or without other intracranial injuries (e.g., epidural hematoma, cerebral contusion, or intracerebral hematoma), and judged by a neurosurgeon to require immediate evacuation of subdural hematoma and decompressive craniectomy; no time limit for the occurrence of trauma or subdural hematoma;

Exclusion criteria

Exclusion criteria: 1.Pupillary dilation caused by non-subdural hematoma reasons; 2.Previous craniocerebral surgery; 3.Concurrent brainstem or spinal cord injury affecting prognosis evaluation; 4.Inability to complete puncture and drainage due to various reasons, such as severe skull fracture; 5.Severe pre-existing physical or mental disabilities or comorbidities that would lead to poor outcomes even if the patient fully recovers from traumatic brain injury; 6.Meeting contraindications for neurosurgery (e.g., uncorrectable severe coagulopathy, severe vital sign instability due to systemic causes); 7.CT and clinical manifestations assessed by a senior neurosurgeon as having no chance of survival (e.g., hemispheric infarction after carotid artery occlusion, or bilateral fixed and dilated pupils with no spontaneous breathing for >1 hour); 8.Recent possibility of pregnancy or confirmed pregnancy;

Design outcomes

Primary

MeasureTime frame
Glasgow Outcome Scale Extended;

Secondary

MeasureTime frame
Serious adverse events and surgical complications;Rate of repeat craniocerebral surgery;Mortality rate;EQ-5D score;Pupillary changes after craniotomy;Readmission to neurosurgery ward;Time from randomization/injury to completion of craniotomy;Pupillary changes after puncture drainage;Time from randomization/injury to skin incision for craniotomy;Hydrocephalus requiring shunt surgery;EQ-5D score;GCS score;Volume of hematoma drained via puncture;ICU length of stay;Intensity of treatment in ICU;Intracranial pressure;Glasgow Outcome Scale Extended;Instrumental Activities of Daily Living;

Countries

China

Contacts

Public ContactHuang Qibing

Qilu Hospital of Shandong University

hqibing@163.com+86 531 82165229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026