Acute subdural haematoma Injury, Occupational Diseases, Poisoning Traumatic subdural haemorrhage
Conditions
Interventions
Following enrolment in the study, suitability for randomisation will be assessed in the operating room by the operating neurosurgeon. A secure web-based randomisation service will be used for the rand
Sponsors
Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extended Glasgow outcome scale; Timepoint(s): at 12 months post-injury | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Extended Glasgow outcome scale at 6 months post-injury 2. Quality of life (EQ-5D) at discharge from neurosurgical unit (NSU), 6 and 12 months post-injury 3. Glasgow Coma Scale (GCS) on discharge from the intensive care unit (ICU) and from NSU 4. Length of stay in ICU, neurosurgical and rehabilitation unit 5. Therapy Intensity Level (IMPACT-TBI scale) in the ICU 6. Discharge destination from NSU 7. Mortality 8. Serious adverse events and surgical complications during index admission 9. Cranial surgery within 2 weeks after randomisation 10. Subsequent readmissions to the NSU within the 12 months follow-up period 11. Hydrocephalus requiring shunt insertion within the 12 months follow-up period 12. Healthcare services utilisation over 12 months 13. Detailed economic evaluation | — |
Countries
Australia, Canada, England, Germany, Greece, Hungary, India, Italy, Malaysia, Pakistan, Scotland, Singapore, Spain, United Kingdom, United States of America, Wales
Contacts
Public ContactCarol Davis-Wilkie
Outcome results
None listed