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Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:Hypertensive intracerebral haemorrhage (HICH) is the most common form of haemorrhagic stroke with the highest morbidity and mortality of all stroke types. The choice of surgical or conservative treatment for patients with HICH remains controversial. In recent years, minimally invasive surgeries, such as endoscopic evacuation and stereotactic aspiration, have been attempted for haematoma removal and offer promise. However, research evidence on the benefits of endoscopic evacuation or stereotactic aspiration is still insufficient. METHODS/DESIGN:A multicentre, randomised controlled trial will be conducted to compare the efficacy of endoscopic evacuation, stereotactic aspiration and craniotomy in the treatment of supratentorial HICH. About 1350 eligible patients from 10 neurosurgical centres will be randomly assigned to an endoscopic group, a stereotactic group and a craniotomy group at a 1:1:1 ratio. Randomisation is undertaken using a 24-h randomisation service accessed by telephone or the Internet. All patients will receive the corresponding surgery based on their grouping. They will be followed-up at 1, 3 and 6 months after surgery. The primary outcome is the modified Rankin Scale at 6-month follow-up. Secondary outcomes include: haematoma clearance rate; Glasgow Coma Scale 7 days after surgery; rebleeding rate; intracranial infection rate; hospitalisation time; mortality at 1 month and 3 months after surgery; the Barthel Index and the WHO quality of life at 3 months and 6 months after surgery. DISCUSSION:The trial aims to investigate whether endoscopic evacuation and stereotactic aspiration could improve the outcome of supratentorial HICH compared with craniotomy. The trial will help to determine the best surgical method for the treatment of supratentorial HICH. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02811614 . Registered on 20 June 2016.

SUBMITTER: Xu X

PROVIDER: S-EPMC5490150 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial.

Xu Xinghua X Zheng Yi Y Chen Xiaolei X Chen Xiaolei X Li Fangye F Zhang Huaping H Ge Xin X

Trials 20170628 1

<h4>Background</h4>Hypertensive intracerebral haemorrhage (HICH) is the most common form of haemorrhagic stroke with the highest morbidity and mortality of all stroke types. The choice of surgical or conservative treatment for patients with HICH remains controversial. In recent years, minimally invasive surgeries, such as endoscopic evacuation and stereotactic aspiration, have been attempted for haematoma removal and offer promise. However, research evidence on the benefits of endoscopic evacuat ...[more]

PMID: 28659171

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Project description:BackgroundTo compare the long-term therapeutic effects of stereotactic aspiration (SA), endoscopic evacuation (EE), and open craniotomy (OC) in the surgical treatment of spontaneous basal ganglia hemorrhage and explore the appropriate clinical indications for each technique.MethodsMultiple-treatment inverse probability of treatment weighting (IPTW)-adjusted logistic regression analysis was performed to evaluate the therapeutic effects of these techniques. The primary and secondary outcomes were 6-month modified Rankin Scale (mRS) and mortality rates, respectively.ResultsA total of 703 patients were ultimately enrolled. For the entire cohort, the 6-month mortality rate was significantly higher (OR 2.396, 95% CI: 1.865-3.080), and the 6-month functional outcome was significantly worse (OR 1.359, 95% CI: 1.091-1.692) for SA than that of EE. The 6-month mortality rate for OC was significantly higher (OR 1.395, 95% CI: 1.059-1.837) than that of EE. Further subgroup analysis was stratified by initial hematoma volume and Glasgow Coma Scale (GCS) score. The mortality rate for SA was significantly higher for patients with hematoma volume of 20-40 mL (OR 6.226, 95% CI: 3.848-10.075), 40-80 mL (OR 2.121, 95% CI: 1.492-3.016), and ≥80 mL (OR 5.544, 95% CI: 3.315-9.269) than in the same subgroups of EE. The functional outcomes for SA were significantly worse than that of EE for hematoma volume subgroups of 40-80 mL (OR 1.424, 95% CI: 1.039-1.951) and ≥80 mL (OR 4.224, 95% CI: 1.655-10.776). The mortality rate for SA was significantly higher than that of EE for the GCS score subgroups of 6-8 (OR 2.082, 95% CI: 1.410-3.076) and 3-5 (OR 2.985, 95% CI: 1.904-4.678). The mortality rate for OC was significantly higher for the GCS score of 3-5 subgroup (OR 1.718, 95% CI: 1.115-2.648), and a tendency for a higher mortality rate of 6-8 subgroup (OR 1.442, 95% CI: 0.965-2.156) than that of EE.ConclusionsEE can decrease the 6-month mortality rate and improve the 6-month functional outcomes of spontaneous basal ganglia hemorrhage in patients with a hematoma volume ≥40 mL. EE can decrease the 6-month mortality rate of spontaneous basal ganglia hemorrhage in patients with a GCS score of 3-8.

Project description:A large number of clinical studies suggested that surgery might be a better choice than conservative treatment for treating hypertensive intracerebral hemorrhage in the middle-aged and elderly. Stereotactic puncture can reduce the mass effect caused by hematoma, reduce the intervention of body homeostasis, reduce brain tissue damage, and improve the prognosis of patients with cerebral hemorrhage. This meta-analysis aims to evaluate the efficacy of stereotactic puncture and craniotomy in elderly patients with hypertensive intracerebral hemorrhage. A search strategy was designed to search in databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials, CNKI, Wanfang database and relevant references. Literature on the efficacy and safety of different surgical methods for hypertensive cerebral hemorrhage in the middle-aged and elderly were retrieved. The search time was until August 17, 2022. Keywords included "hypertensive intracerebral hemorrhage," "stereotactic hematoma removal," "craniotomy." After the literature search, 2 researchers independently conducted literature screening, quality evaluation of included trials and data extraction. RevMan5.4 software was used to perform a Meta-analysis on the operation time, hospital stay, postoperative Glasgow Coma Scale (GCS) score, postoperative daily activity ability, postoperative complications and neurological prognosis scores included in the included studies. A total of 1988 samples were included in 9 studies. 1022 patients underwent stereotactic hematoma removal, and 968 patients underwent craniotomy hematoma removal. The orientation group had more advantages in the length of hospital stay, postoperative disability, pulmonary infection, intracranial infection and digestive tract ulcer, and the difference was statistically significant (P < .05). In addition, the length of stay (I²= 83%) of the included articles had good homogeneity (I²< 50%), and there was no significant difference between the 2 groups in operation time, postoperative GCS score, postoperative daily activity ability, and neurological prognosis score (P > .05). The meta-analysis indicate that compared to craniotomy for hematoma removal, stereotactic hematoma removal can reduce the postoperative disability rate, intracranial infection rate, lung infection rate, and digestive tract ulcer rate in middle-aged and elderly patients with hypertensive intracerebral hemorrhage.

Project description:Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage.MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18-80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0·3 mg or 1·0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered with ClinicalTrials.gov, number NCT00224770.Between Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9·5%, 95% CI 2·7-22.6] vs eight [14·8%, 6·6-27·1], p=0·542), 7 day mortality (zero [0%, 0-8·4] vs one [1·9%, 0·1-9·9], p=0·562), symptomatic bleeding (one [2·4%, 0·1-12·6] vs five [9·3%, 3·1-20·3], p=0·226), and brain bacterial infections (one [2·4%, 0·1-12·6] vs zero [0%, 0-6·6], p=0·438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22·2%; 95% CI 12·0-35·6] vs three [7·1%; 1·5-19·5]; p=0·051).MIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage.National Institute of Neurological Disorders and Stroke, Genentech, and Codman.

Project description:ObjectivesOverwork-related cerebrovascular and cardiovascular diseases (CCVDs) constitute a major occupational and public health issue worldwide. However, to our knowledge, few studies have reported the underlying pathophysiological mechanisms. We aimed to determine whether patients with extreme workload have a greater risk of developing hypertensive intracerebral haemorrhage (ICH) located in the deep brain areas than patients without extreme workload. We also determined the association between the number of hours of overtime work and the risk of developing hypertensive ICH.DesignUnmatched case-control study.SettingDatabase of patients claiming compensation for overwork-related CCVDs in Japan.ParticipantsA total of 1215 patients who claimed overwork-related ICH in Japan, of whom 621 had their compensation claim approved (patients with extreme workload) and 622 did not.Primary and secondary outcome measuresLogistic regression analysis was performed to calculate the risk of developing hypertensive ICH in patients with extreme workload compared with those without extreme workload, adjusted for confounders such as age, occupation, smoking status, alcohol consumption and medical history. We also calculated the risk of developing hypertensive ICH in compensated patients by average monthly overtime working hours.ResultsPatients with extreme workloads had a significantly higher odds ratio (OR) for developing hypertensive ICH (1.44, 95% CI: 1.10 to 1.88) than those without extreme workloads. ORs for developing hypertensive ICH according to overtime working hours showed a dose-response relationship; an overtime of 100 hours/month was associated with a significantly higher OR (1.31, 95% CI: 0.89 to 1.91; 1.41, 95% CI: 0.95 to 2.11; and 1.50, 95% CI: 1.01 to 2.22 for 60-79.9, 80-99.9 and≥100 hours/month, respectively) than that for workloads of less than 60 hours/month.ConclusionsRegarding Japanese workers, overtime work could be associated with the risk of developing hypertensive ICH, and hypertension may play an important role in overwork-related ICH.

Dataset Information

Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial.

Publications

Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial.

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