Journal club 24/10/2016 Presented by Pitchayud Kantachuvesiri Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension (RESCUEicp Trial) Journal club 24/10/2016 Presented by Pitchayud Kantachuvesiri

Background Traumatic brain injuruy Intracranial Hypertension Decreased Cerebral Perfusion pressure Brain Ischaemia / increase in mortality Decompressive Craniectomy: Primary: time of mass lesion evacuation Secondary: refractory raised ICP Previous RCT, decompressive craniectomy (DECRA) trial showed that secondary decompressive craniectomy was associated with unfavourable outcomes than standard care alone.

Methods Randomised control trial Compared “last tier” secondary decompressive craniectomy with continued medical management only. Patients aged 10 – 65 Abnormal CT following TBI Raised ICP above 25mmHg for 1- 12 hrs following medical management. Patients with prior neurosurgery (excluding craniectomy) were included Randomisation using “permuted blocks of random sizes” Surgeons choice of unilateral or bifrontral craniectomy and should be performed 4-6 hrs after randomisation Patients in medical management group could later have craniectomy if treating clinician felt was needed.

Outcomes Primary outcome: extended glasgow outcome scale (GOS-E) at 6 months after randomisation. Questionnaires mailed to surviving participants, phone call if no reply. Local investigators at international sites. Secondary Outcomes: GOS-E at 12 and 24 months, mortality at 6, 12 and 24 months, quality of life (36 item short form survey) at 6,12,24 months after randomisation. GCS on discharge from ICU. Target: 400 patients required for the trial for statistical analysis.

Glasgow Outcome Scale - extended 1 = Dead 2 = Vegetative State Condition of unawareness with only reflex responses but with periods of spontaneous eye opening. 3 = Low Severe Disability 4 = Upper Severe Disability Patient who is dependent for daily support for mental or physical disability, usually a combination of both. If the patient can be left alone for more than 8h at home it is upper level of SD, if not then it is low level of SD. 5 = Low Moderate Disability 6 = Upper Moderate Disability Patients have some disability such as aphasia, hemiparesis or epilepsy and/or deficits of memory or personality but are able to look after themselves. They are independent at home but dependent outside. If they are able to return to work even with special arrangement it is upper level of MD, if not then it is low level of MD. 7 = Low Good Recovery 8 = Upper Good Recovery Resumption of normal life with the capacity to work even if pre-injury status has not been achieved. Some patients have minor neurological or psychological deficits. If these deficits are not disabling then it is upper level of GR, if disabling then it is lower level of GR.

Results 408 patients under went randomisation (across 20 countries) Another 10 dropped out due to consent issues 202 patients surgical group vs 196 medical Baseline characteristics of both groups similar at baseline except fewer alcohol abuse in surgical group vs medical. Both groups received similar interventions in stage 1 and 2 of the trial before randominsation. Including no significant different in craniotomies performed 87.2% received barbituate infusion in medical group

Outcome GOS-E at 6 months Death: 26.9% (surg) vs 48.9% (med) Vegetative state: 8.5% vs 2.1% Lower severe disability: 21.9% vs 14.4% Upper severe disability: 15.4% vs 8.0% Lower moderate disability: 10% vs 10.1% Upper moderate disability: 13.4% vs 9.6% Lower good recovery: 2.5% vs 3.2% Upper good recovery: 1.5% vs 3.7% For every 100 patients treated surgically, 22 more survivors GOS-E at 12 months Death: 30.4% vs 52.0% VS: 6.2% vs 1.7% LSD: 18% vs 14% USD: 13.4% vs 3.9% LMD: 10.3% vs 7.8% UMD: 11.9% vs 12.3% LGR: 7.2% vs 3.9% UGR: 2.6% vs 4.5%

Discussion Increasing survival but more disability Favourable outcomes: Surgical 42.8% vs Medical 34.6% - Upper severe disability or better (non-significant statistically) Optional stage 1 and 2 treatments were similar in 2 groups Limitations Clinical teams not blinded with patients groups (questionnaires teams were) 37.2% of medical patients had craniectomies Cranial Reconstruction not analysed Primary Decompressive craniectomy not tested

Conclusion “At 6 months, decompressive craniectomy for refractory intracranial hypertension after TBI resulted in lower mortality, higher rates of vegetative state, lower severe disability, and upper severe disability than medical management. The rates of moderate disability and good recovery were similar to those with medical management”

Comments from Meeting Wide inclusion criteria of patients Varied time from raised icp to intervention (1-2 12 hours) 37% Medical group having craniectomy Does not take into account quality/quantity rehab post event