The significance of crossovers after randomization in the STICH trial

Prasad, Kuskoor Seetharam Manjunath; Gregson, BA; Bhattathiri, P. S.; Mitchell, Patrick; Mendelow, A. D.

doi:10.1007/3-211-30714-1_15

Cited by 19 publications

(9 citation statements)

References 6 publications

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“…Surgical treatment results were found to be superior to medical treatment results in subcortical (1,23,24,26), putaminal (22,23,26) right sided (24), lobar (24) hematomas, in large hematoma volume (>5cm diameter or >50ml volume) (22,24,26), in hematomas that caused a big shift (24) and in patients with moderate GCS (7,14,23). Early surgery improves surgical results, thus to be preferred (15,24,26).…”

Section: Discussionmentioning

confidence: 96%

“…-Mortality was seemed to be lower in the surgical group compared with the medical group at 1st month, but similar at 6th months (21) -Analysis of the secondary 3-month outcome measures showed a nonsignificant trend toward a better outcome in the surgical versus medical for the median GOS, Barthel Index, and Rankin Scale and a significant difference in the National Institutes of Health Stroke Scale score (7,13,29) -A significant ICH volume reduction was achieved by the intervention (7,19,27) -Early surgery in patients with putaminal and subcortical haematomas with ICH> 50 ml is superior (6,22,23,26) -Surgery was to be preferred when ICH had these features: Right side, lobar location, superficial, large volume, big shift, and early diagnosed and treated patients (23,24,26) -In hematomas >5cm the surgical treatment results were significantly better (22,23) The main question to be answered is which cases we should operate?…”

Section: The Studies Reporting Medical Treatment Is Advantageous Overmentioning

confidence: 99%

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Meta-analyses of intracerebral hematoma treatment

Anık

Seçer²,

Anık³

et al. 2010

Turkish Neurosurgery

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AIm:The aim of this study is to define the position of surgery preference in the treatment choice for spontaneous intracerebral hematoma (ICH) and to compare the efficacy of surgery with the medical treatment based on data from 18 previously reported randomized prospective studies on this topic. mAterIAl and methOds: Literature databases and articles were searched from 1960 to 2010. Eighteen randomized studies on this topic were evaluated. results: Among these 18 studies, 7 (38.9%) were multicenter and 11 (61.1%) were single center. Totally 204 centers were involved. 1769 patients were treated surgically and 3200 medically. Craniotomy was the most preferred method (n=14; 77.8%). Follow-up time was mostly 6 months. In general, the effect of surgical versus medical treatment on outcome (mortality/morbidity) after a supratentorial spontaneous ICH do not differ significantly. In individual analysis, the mortality was found to be significantly lower in the operated group than the nonoperated group in only two studies (Kurtsoy's and Miller's studies). Meta-analysis of subgroup analysis revealed surgical treatment results were significantly better for hematoma volume >40ml, early surgery (before 24 hours), and Glasgow Coma Scale (GCS)≥6.COnClusIOn: Surgical treatment results were found to be superior to medical treatment in cases with hematoma volume >40ml, and GCS≥6. The studies are not adequate to analyze the best type of surgery. KeywOrds:Intracerebral hematoma, Meta-analyses, Surgery, Glasgow coma scale ÖZ AmAÇ: Bu çalışmanın amacı, spontan intraserebral hematomun tedavisinde daha önceden yazılmış 18 randomize prospektif çalışmanın bulgularına dayanarak cerrahi tercih durumlarını belirlemek ve medikal ile cerrahi tedavi sonuçlarının etkinliğini karşılaştırmaktır. yÖntem ve GereÇ: 1960-2010 yılları arasında veritabanları taranarak ilgili makaleler araştırıldı. Bu konu üzerine 18 randomize çalışma değerlendirildi.BulGulAr: On sekiz çalışmanın 7si (%38,9) çok merkezli, 11'i (%61,1) tek merkezliydi. Toplam 204 merkez dahildi. 1769 hastaya cerrahi, 3200 hastaya medikal tedavi uygulandı. Kraniotomi en çok tercih edilen yöntemdi (n=14;%77,8). Takip süresi çoğunlukla 6 aydı. Genel olarak supratentorial spontan ICH sonrası sonuçlarda (mortalite ve morbiditede) cerrahinin medikal tedaviye etkinliği anlamlı farklı bulunmadı. Bireysel analizlerde sadece iki çalışmada(biri Kurtsoy'un ve diğeri Miller'ın) mortalite opere olan grupta opere olmayanlara göre daha düşük bulundu. Alt grupların meta-analizinde cerrahi tedavi hematom hacmi 40 ml üstünde, erken cerrahide (24 saatten önce), Glasgow koma skalası 6 ve üzerinde anlamlı üstün bulundu. sOnuÇ: Hematom hacmi 40 mlden büyük, GCS 6 ve üzerinde olgularda cerrahi sonuçlar medikal tedaviden üstün bulundu. Çalışmalar en iyi cerrahi tipini belirlemek için yeterli değildir.

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Section: Discussionmentioning

confidence: 96%

Section: The Studies Reporting Medical Treatment Is Advantageous Overmentioning

confidence: 99%

Meta-analyses of intracerebral hematoma treatment

Anık

Seçer²,

Anık³

et al. 2010

Turkish Neurosurgery

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“…Despite the data available from well designed studies, especially from the Surgical Trial in Intracerebral Haemorrhage (STICH), there is incertitude about which is the proper treatment in a particular patient with spontaneous supratentorial intracerebral haemorrhage 3,6,8,15,16,17,18,19,21,22 . The variability among patients, as well as the great number of factors that influence their outcome, are important issues to take into account.…”

Section: Discussionmentioning

confidence: 99%

Early mortality in spontaneous supratentorial intracerebral haemorrhage

et al. 2010

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SummaryBackground. Spontaneous supratentorial intracerebral haemorrhage is a severe, frequent, and poorly understood condition. Despite the publication of 12 randomised controlled trials on this subject, the role of surgery remains controversial and no treatment has proved to be effective. We report on a ten year prospective cohort study based on a defined population treated with or without surgery and their outcome in terms of early survival.Methods. Population based, ten year prospective observational study directed to patients consecutively admitted to the Intensive Care Unit (ICU) in a tertiary centre with spontaneous supratentorial intracerebral haemorrhage. Patients were distributed in five groups according to the Glasgow Coma Score (GCS) at admission. Haemorrhages were classified as deep-seated or superficial. All patient received standard medical care, and additionally surgery if it was found indicated by the duty neurosurgeon. Primary endpoint was early mortality defined as dead occurred by any cause during the admission in the ICU.Findings. During the ten year period, 1.485 patients were admitted to our centre with primary intracerebral haemorrhage. Of these, 376 were admitted to the intensive care unit and 285 sustained supratentorial haemorrhages. Low GCS was strong predictor of early mortality. Despite the larger size of haematomas in patients undergoing surgical evacuation, surgery was associated with lower early mortality in all GCS subgroups. Maximal benefit was observed in patient with admission GCS of 4-8. Superficial haematomas were operated on more often, and were associated with lower mortality rate than deep-seated cases.Conclusions. Our findings suggest that craniotomy for haematoma evacuation may reduce early mortality in patients with primary supratentorial intracerebral haemorrhage. Surgery seems specially useful in patients with admission GCS between 4 and 8, and in those with superficial haemorrhages.

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“…Out of these 29 patients were not included in the study due to unable to fulfill the selection criteria. Fourteen (14) patients underwent surgical evacuation while seventeen (17) patients those who didn't give consent for operation were selected for conservative therapy. Therefore a total of 31 patients were enrolled in this study.…”

Section: Resultsmentioning

confidence: 99%

Outcome of Surgical Management in Spontaneous Supratentorial Intracerebral Hemorrhage Patients: A Randomized Control Trial

Islam

Haque

Khan

et al. 2018

J. Natl Inst. Neurosci Bangladesh

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Background: Management of spontaneous supratentorial intracerebral hemorrhage is crucial. Objective: The purpose of the present study was to compare the outcome of surgery in relation to conservative management of spontaneous supratentorial intracerebral hemorrhage. Methodology: This was a single centred, parallel randomized control trial which was conducted in the Department of Neurosurgery at Dhaka Medical College and Hospital from January 2010 to October 2011 for a period of one year and ten months. All hypertensive patients with spontaneous supratentorial intracerebral hemorrhage who were admitted within 48 hours of stroke in Neurosurgery Department during the study period were considered as a study population. Patients underwent surgery was considered as group I and patients those who did not give the consent for operation were treated conservatively was considered as group II. Surgery and conservative groups were matched in age. Result: A total of 31 patients were enrolled in this study. Fourteen (14) patients underwent surgical evacuation while seventeen (17) patients those who didn't give consent for operation were selected for conservative therapy. The distribution of the study patients according to GOS (30 days) that 6(42.9%) and 10 (58.8%) patients in surgery and conservatively managed patients were dead respectively; however, 4(28.6%) patients in surgery and 3(17.6%) patient in conservative group had good recovery. Besides, 2(14.3%) surgery patients and 3(17.6%) conservative patients were severe disabled. Moreover, 2(14.3%) surgery patients and 1(5.9%) conservative patients were moderately disabled. Conclusion: In conclusion surgical evacuation of spontaneous supratentorial intracerebral hemorrhage has a benefit on outcome compared to conservative medical treatment.

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The significance of crossovers after randomization in the STICH trial

Cited by 19 publications

References 6 publications

Meta-analyses of intracerebral hematoma treatment

Meta-analyses of intracerebral hematoma treatment

Early mortality in spontaneous supratentorial intracerebral haemorrhage

Outcome of Surgical Management in Spontaneous Supratentorial Intracerebral Hemorrhage Patients: A Randomized Control Trial

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