The full guideline can be found at: https://braintrauma.org/guidelines/guidelines-for-the-management-of-severe-tbi-4th-ed#/.
DECRA10 and RESCUEicp11 are higher quality studies whose findings supersede those of lesser quality investigations. Though both studied secondary DC for the treatment of refractory ICP elevation, a key difference in the study protocols for DECRA10 and RESCUEicp11 is that they were designed to investigate conditions of early and late refractory ICP elevations, respectively. Indeed, DECRA enrolled TBI patients with ICP above 20 mm Hg for 15 min over a 1-h period despite the optimization of tier 1 treatments within the first 72 h of care (early), while RESCUEicp enrolled patients with ICP greater than 25 mm Hg for 1 to 12 h refractory to 2 tiers of treatment within 10 d of admission (late). In constructing the recommendations that follow, we thus refer to early and late refractory ICP elevations to reference conditions similar to those studied in DECRA and RESCUEicp, respectively.
The addition of these studies to the available research evidence is the basis for the following updated recommendations:
Level IIA–to improve mortality and overall outcomes
1. NEW–Secondary DC performed for late refractory ICP elevation is recommended to improve mortality and favorable outcomes.
2. NEW–Secondary DC performed for early refractory ICP elevation is not recommended to improve mortality and favorable outcomes†.
3. A large frontotemporoparietal DC (not less than 12 × 15 cm or 15 cm in diameter) is recommended over a small frontotemporoparietal DC for reduced mortality and improved neurological outcomes in patients with severe TBI.
Level IIA–for ICP control
4. NEW–Secondary DC, performed as a treatment for either early or late refractory ICP elevation, is suggested to reduce ICP and duration of intensive care, though the relationship between these effects and favorable outcome is uncertain.
†Recommendation #2 should not be extrapolated to primary DC in which the bone flap is left off when an intracranial mass lesion is evacuated early after injury.
The recommendations for DC in the fourth edition (2017) were as follows:
“Bifrontal DC is not recommended to improve outcomes as measured by the Glasgow Outcome Scale-Extended (GOS-E) score at 6 months post-injury in severe TBI patients with diffuse injury (without mass lesions), and with ICP elevation to values > 20 mm Hg for more than 15 minutes within a 1-h period that are refractory to first-tier therapies. However, this procedure has been demonstrated to reduce ICP and to minimize days in the intensive care unit (ICU).
A large frontotemporoparietal DC (not less than 12 × 15 cm or 15 cm diameter) is recommended over a small frontotemporoparietal DC for reduced mortality and improved neurologic outcomes in patients with severe TBI.”12
The first recommendation was based on the 6-mo outcomes from DECRA.9 The second recommendation was based on 2 studies: Jiang et al (2005)14 and Qiu et al (2009).15
By virtue of the updated body of evidence, including 12-mo outcome data from DECRA and RESCUEicp, both published subsequent to the 2017 guidelines, we have removed the first recommendation and restated the second. We also provide 3 new level-IIA recommendations. New recommendation #1 relates to the positive findings of the RESCUEicp study,11 while new recommendation #2 relates to the negative findings of the DECRA study.9,10 Recommendation #4 reflects findings consistent in both studies.9-11
The scope of this update was limited to the addition of the RESCUEicp study and the 12-mo DECRA outcome data to the existing body of evidence. Following the appraisal and addition of this evidence, we assessed whether changes to the 2017 recommendations were appropriate. The methodology and analytical framework employed were consistent with those used for the previously published fourth edition.12
To complete these tasks, we assembled a subcommittee comprising a senior methodologist and 2 clinical investigators who were authors of the DC section of the 2017 guidelines document.12 The work of this subgroup was then presented to all authors of the fourth edition guidelines. The updated recommendations were then extensively discussed and revised.