Therapy
Decompressive craniectomy in diffuse traumatic brain injury.
This review may be edited
Summary
Posted By: Elizabeth Sweetman & Gordon Doig
E-Mail: esweetman@med.usyd.edu.au
Posted Date: 19.03.2013
Title: Decompressive craniectomy in diffuse traumatic brain injury.
Authors: Cooper DJ, Rosenfeld JV, Murray L, Arabi YM, Davies AR, D'Urso P, Kossmann T, Ponsford J, Seppelt I, Reilly P, Wolfe R; DECRA Trial Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group.
Reference: N Engl J Med. 2011 Apr 21;364(16):1493-502.
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: BACKGROUND: It is unclear whether decompressive craniectomy improves the functional outcome in patients with severe traumatic brain injury and refractory raised intracranial pressure.
METHODS: From December 2002 through April 2010, we randomly assigned 155 adults with severe diffuse traumatic brain injury and intracranial hypertension that was refractory to first-tier therapies to undergo either bifrontotemporoparietal decompressive craniectomy or standard care. The original primary outcome was an unfavorable outcome (a composite of death, vegetative state, or severe disability), as evaluated on the Extended Glasgow Outcome Scale 6 months after the injury. The final primary outcome was the score on the Extended Glasgow Outcome Scale at 6 months.
RESULTS: Patients in the craniectomy group, as compared with those in the standard-care group, had less time with intracranial pressures above the treatment threshold (P<0.001), fewer interventions for increased intracranial pressure (P<0.02 for all comparisons), and fewer days in the intensive care unit (ICU) (P<0.001). However, patients undergoing craniectomy had worse scores on the Extended Glasgow Outcome Scale than those receiving standard care (odds ratio for a worse score in the craniectomy group, 1.84; 95% confidence interval [CI], 1.05 to 3.24; P=0.03) and a greater risk of an unfavorable outcome (odds ratio, 2.21; 95% CI, 1.14 to 4.26; P=0.02). Rates of death at 6 months were similar in the craniectomy group (19%) and the standard-care group (18%).
CONCLUSIONS: In adults with severe diffuse traumatic brain injury and refractory intracranial hypertension, early bifrontotemporoparietal decompressive craniectomy decreased intracranial pressure and the length of stay in the ICU but was associated with more unfavorable outcomes. (Funded by the National Health and Medical Research Council of Australia and others; DECRA Australian Clinical Trials Registry number, ACTRN012605000009617.).
 
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
Yes. Patients were randomised by an automated telephone system to either undergo a bifrontotemporoparietal decompressive craniectomy or receive standard care.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
Yes. All 155 enrolled patients (73 patients in Decompressive Craniectomy Group & 82 Patients in the Standard Care Group) were accounted for and analysed at the completion of trial recruitment. There was no loss to follow-up in either trial arm (Refer to Figure 1 Supplementary Appendix).
2b. Were patients analyzed in the groups to which they were randomized?
Yes all patients were analysed to the groups to which they were randomised.
3. Were patients, health workers, and study personnel blind to treatment?
Assessment of primary outcome measures was blinded. Three trained assessors (study personnel) who evaluated outcome measures by telephone were unaware of study group assignment
4. Were the groups similar at the start of the trial?
Treatment groups were mostly similar at the start of the trial, however, fewer Patients in the Craniectomy group had reactive pupils compared to the Standard Care Group (19/71 vs 10/80, P = 0.04), Table 1, Page 1496.
5. Aside from the experimental intervention, were the groups treated equally?
Patients assigned to the Craniectomy Group required fewer interventions to decrease intracranial pressure compared to Patients in the Standard Care Arm (Table 2 Supplementary Appendix) including less Hypertonic Saline, Mannitol, Neuromuscular Blockades, Venting of cerebrospinal Fluids, Barbituates.
What are the Results?
1. How large was the treatment effect?
Primary Outcome (Table 2, page 1499)
Functional Outcomes at 6 Months after Injury assessed by Extended Glasgow Outcomes Scale
Extended outcomes scale at 6 months worse in Crainectomy group vs Standard Care group, Odds ratio 1.84, P = 0.03
After adjustment for pupil reactivity, there was no statistical difference in Extended outcomes scale at 6 months between Crainectomy group and Standard Care group, adjusted odds ratio 1.53, P = 0.15. Although the statistical significance disappeared, the 95% CI (see below) does not suggest any meaingful potential for benefit.
Secondary Outcomes
Mortality : No difference between Craniectomy Group vs Standard Care Group (19% vs 18%)
2. How precise was the estimate of the treatment effect?
Primary Outcome - Functional Outcomes at 6 Months after Injury assessed by Extended Glasgow Outcomes Scale : Adjusted Odds Ratio 1.53, 95% CI 0.86 - 2.73, P = 0.15)
Secondary Outcomes - Risk of Unfavourable Outcome : Adjusted for pupillary reactivity Odds Ratio 1.90, 95% CI 0.95 - 3.79, P = 0.15)
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
Yes. This trial is conducted in Australian and New Zealand Intensive Care Units.
2. Were all clinically important outcomes considered?
Yes all clinically important outcomes were considered.
3. Are the likely treatment benefits worth the potential harms and costs?
There were no signs of benefit in the bifrontotemporoparietal decompressive craniectomy group.
Decompressive craniectomy may be causing more patients to remain in a Persistent vegetative state.

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Decompressive craniectomy in diffuse traumatic brain injury.

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