Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: craniectomy, bone flap is not kept back after evacuation of acute subdural hematoma with craniotomy,Bone flap is kept back after evacuation of acute subdural hematoma.: craniotomy and
d
Sponsors
Cambridge University Hospitals NHS Foundation Trust and Cambridge Clinical Trials Unit CCTU
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult head-injured patients (age more than 16 years) 2 Acute subdural haematoma on CT 3 The admitting neurosurgeon feels that the haematoma needs to be evacuated with a large bone flap (recommended size more than 11 cm anteroposterior diameter) either by a craniotomy or decompressive craniectomy Patients with additional lesions (such as intracerebral haemorrhage/contusions) may be included
Exclusion criteria
Exclusion criteria: 1 Bilateral acute subdural haematomas both requiring evacuation 2 Previous enrolment in 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To detect an 8% absolute difference in the rate of favourable outcome between decompressive craniectomy (43%) and craniotomy (35%) with a power of 90% and a 2-sided significance of 5%. This corresponds to an 8% treatment effect. Timepoint: 1year | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events and surgical complications Timepoint: 1year;detailed economic evaluationTimepoint: 1year;long-term clinical effectiveness of decompressive craniectomy versus craniotomy Timepoint: 1year | — |
Countries
India, United Kingdom
Contacts
Public ContactBhagavatula Indira devi
National Institute of Mental Health and Neurosciences
Outcome results
None listed