Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma (RESCUE-ASDH)

Not Applicable

Completed

Conditions: Acute subdural haematoma
Injury, Occupational Diseases, Poisoning
Traumatic subdural haemorrhage

Registration Number: ISRCTN87370545

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)

Brief Summary: 2023 Results article in https://doi.org/10.1056/nejmoa2214172 (added 25/04/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38885989/ Cost evaluation (added 25/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 463

Inclusion Criteria

Participant inclusion criteria as of 04/12/2018:
1. Adult head-injured patients (>16 years)
2. Acute subdural haematoma on CT*
3. The admitting neurosurgeon feels that the haematoma needs to beevacuated with a large bone flap (recommended size =11 cm anteroposterior diameter) either by a craniotomy or decompressive craniectomy
*Patients with additional lesions (e.g. intracerebral haemorrhage, contusions) can be included

Previous participant inclusion criteria:
1. Adult head-injured patients (>16 years)
2. Acute subdural haematoma on CT*
3. The admitting neurosurgeon feels that the haematoma needs to be evacuated either by a craniotomy or decompressive craniectomy (bone flap at least 11 cm in both instances )*
*Patients with additional lesions (e.g. intracerebral haemorrhage, contusions) can be included

Exclusion Criteria

Participant exclusion criteria as of 04/12/2018:
1. Bilateral acute subdural haematomas both requiring evacuation
2. Previous enrolment in the RESCUE-ASDH study
3. Severe pre-existing physical or mental disability or severe co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury

Previous participant exclusion criteria:
1. Bilateral unresponsive dilated pupils of =5 mm and/or brainstem injuries on CT
2. Uncorrected coagulopathy
3. Bilateral acute subdural haematomas both requiring evacuation
4. Previous enrolment in the RESCUE-ASDH study
5. Severe pre-existing physical or mental disability or severe co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extended Glasgow outcome scale; Timepoint(s): at 12 months post-injury

Secondary Outcome Measures

Name	Time	Method
1. Extended Glasgow outcome scale at 6 months post-injury <br>2. Quality of life (EQ-5D) at discharge from neurosurgical unit (NSU), 6 and 12 months post-injury <br>3. Glasgow Coma Scale (GCS) on discharge from the intensive care unit (ICU) and from NSU <br>4. Length of stay in ICU, neurosurgical and rehabilitation unit <br>5. Therapy Intensity Level (IMPACT-TBI scale) in the ICU <br>6. Discharge destination from NSU <br>7. Mortality <br>8. Serious adverse events and surgical complications during index admission <br>9. Cranial surgery within 2 weeks after randomisation <br>10. Subsequent readmissions to the NSU within the 12 months follow-up period <br>11. Hydrocephalus requiring shunt insertion within the 12 months follow-up period <br>12. Healthcare services utilisation over 12 months <br>13. Detailed economic evaluation