1. 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

2. 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.

3. 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 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.

5. 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.

6. 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.

7. 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

8. 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%

9. 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

10. 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”

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