|Year : 2017 | Volume
| Issue : 4 | Page : 759--760
Operation versus non-operative treatment for spontaneous supratentorial intracerebral haemorrhage: Is a change in current clinical practice required?
A David Mendelow
Institute of Neuroscience, Neurosurgical Trials Group, Newcastle University, Wolfson Research Centre, Campus for Ageing and Vitality, Westgate Road, Newcastle upon Tyne, United Kingdom
A David Mendelow
Institute of Neuroscience, Neurosurgical Trials Group, Newcastle University, Wolfson Research Centre, Campus for Ageing and Vitality, Westgate Road, Newcastle upon Tyne, NE4 5PL
|How to cite this article:|
Mendelow A D. Operation versus non-operative treatment for spontaneous supratentorial intracerebral haemorrhage: Is a change in current clinical practice required?.Neurol India 2017;65:759-760
|How to cite this URL:|
Mendelow A D. Operation versus non-operative treatment for spontaneous supratentorial intracerebral haemorrhage: Is a change in current clinical practice required?. Neurol India [serial online] 2017 [cited 2020 Nov 24 ];65:759-760
Available from: https://www.neurologyindia.com/text.asp?2017/65/4/759/209600
In this randomised controlled trial of operation versus non-operative treatment for spontaneous supratentorial intracerebral haemorrhage, Bhaskar et al., from Lucknow describe a small single centre trial in which sixty-one patients with a Glasgow Coma Score of between 4 and 14 were randomised where the haematoma volume was greater than 30 mls. The randomisation was slightly asymmetrical in that twenty seven were randomised to receive medical management (MM) alone and thirty four were randomised to combined surgical medical management (SM). They state that the primary and secondary outcomes where mortality and dependency at three months respectively. With MM only 7% achieved a good Rankin score (0 to 3) compared with 9% following surgery. These were large haematomas in patients who were all kept in the intensive care unit environment. This makes the trial somewhat unique in that every single patient was looked after in the same environment thus obviating any criticism that different standards of care might have been applied to the non-surgical patients. The surgical treatment was always a craniotomy. The haematomas were large and more than eighty percent were in the basal ganglia, which is very different from the STICH II Trial where the patients had superficial haematomas always within one centimetre of the cortical surface of the brain itself. In this Lucknow Trial, 90% – 100% of patients had pupillary asymmetry. As was seen in the STICH II Trial, mortality was reduced (from 85% in the MM group to 62 percent in the SM group) and this was significant (P = 0.043). However, the patients' dependency was greater in the SM group and the overall poor results (dead and dependant or Rankin 4 to 6) were therefore 93 percent in the MM group compared with 91 percent in the SM group. This figure is difficult to read from the paper but it is clear that 23 patients died in the MM group and 21 died in the SM group. There were only two patients with the Rankin 0-3 that survived in the MM group of 27 all together so that 25 patients were dead or disabled (93%). There were three good survivors (Rankin 0-3) in the SM group of 34 patients so that all together 31 out of 34 had a poor outcome (dead or disabled) [Rankin 4, 5 or 6]. This gives an overall poor outcome rate of 91%. This was clearly not significant and therefore the trial is overall neutral if analysed the way all other randomised control trials of spontaneous intracerebral haemorrhage have been analysed. This trial therefore adds to the sixteen previous randomised control trials of surgery for intracerebral haemorrhage where clot evacuation is successful but where the overall poor outcomes (death and disability) have never been sufficiently impressive to change practice.
Minimally Intervention Surgery shows greater promise of a more favourable outcome in meta-analysis compared with Craniotomy. The MISTIE III Trial is a Randomised Controlled trial of Minimally Intervention Surgery. This MISTIE III trial is ongoing (nearly 500 patients randomised to date) and one year follow up should be completed by the summer of 2018. It is possible that this minimal intervention approach in MISTIE III may have better outcomes than all of the previous trials and their meta-analysis but time will tell.
Overall it looks as if surgeons can successfully remove clots but that the benefit is so small to date that the number needed to treat is too large to change clinical practice. It seems that this trial from Lucknow confirms the previous clinical trial work.,,
|1||Bhaskar MK, Kumar R, Ojha BK, Singh SK, Verma N, Verma R, et al. A randomized controlled study of operative versus non-operative treatment for large spontaneous supratentorial intracerebral haemorrhage. Neurol India 2017;65:752-58.|
|2||Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM. STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): A randomised trial. Lancet. 2013;382:397-408.|
|3||MISTIE III (Minimally Invasive Surgery Plus rt-PA for Intracerebral Hemorrhage Evacuation) Clinical Trial. ClinicalTrials.gov Identifier: NCT01827046. Available from: http://braininjuryoutcomes.com/mistie-iii-about [Last accessed on 2017 Jun 29].|
|4||Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, et al. STICH investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): A randomised trial. Lancet. 2005;365:387-97.|
|5||Mendelow AD, Teasdale GM, Barer D, Fernandes HM, Murray GD, Gregson BA. Outcome assignment in the International Surgical Trial of Intracerebral Haemorrhage. Acta Neurochir (Wien) 2003;145:679-81.|