scholarly journals The Relationship Between Timing of Surgery and Operative Complications in Aneurysmal Subarachnoid Hemorrhage

1987 ◽  
Vol 14 (S1) ◽  
pp. 84-87 ◽  
Author(s):  
William S. Tucker
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Aneurysm Rupture ◽  
Timing Of Surgery ◽  
Optimal Timing ◽  
Double Blind ◽  
Technical Problems ◽  
University Of Toronto ◽  
Surgical Technical ◽  
Aneurysm Repair

ABSTRACT:The optimal timing of definitive aneurysm repair following subarachnoid hemorrhage remains a controversial issue. In order to examine whether the timing of surgery alters the incidence of certain technical difficulties and complications associated with intracranial aneurysm repair, data from two recent co-operative studies were examined. The cases submitted to the International Co-operative Study on Timing of Aneurysm Surgery by the University of Toronto hospitals, and the cases submitted from multiple centres to the Three-Dose Multicentre Randomized Double-Blind Nimodipine Study were evaluated with regard to operative difficulties and complications, comparing early (≤ 3 days) and late (≥ 4 days) surgery following subarachnoid hemorrhage. No significant differences were found in the incidence of such technical problems between the early and late surgical groups. If differences in outcome occur between comparable groups of patients operated early and late after aneurysm rupture, factors other than surgical technical complications may be responsible.

scholarly journals Twenty-four–hour emergency intervention versus early intervention in aneurysmal subarachnoid hemorrhage

2018 ◽  
Vol 128 (5) ◽  
pp. 1297-1303 ◽  
Author(s):  
Joseph R. Linzey ◽  
Craig Williamson ◽  
Venkatakrishna Rajajee ◽  
Kyle Sheehan ◽  
B. Gregory Thompson ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Aneurysm Rupture ◽  
Ruptured Aneurysms ◽  
Academic Center ◽  
Diagnostic Angiography ◽  
Rebleeding Rate ◽  
Independent Review ◽  
Critical Care Management ◽  
Aneurysm Repair

OBJECTIVERecent observational data suggest that ultra-early treatment of ruptured aneurysms prevents rebleeding, thus improving clinical outcomes. However, advances in critical care management of patients with ruptured aneurysms may reduce the rate of rebleeding in comparison with earlier trials, such as the International Cooperative Study on the Timing of Aneurysm Surgery. The objective of the present study was to determine if an ultra-early aneurysm repair protocol will or will not significantly reduce the number of incidents of rebleeding following aneurysmal subarachnoid hemorrhage (SAH).METHODSA retrospective analysis of data from a prospectively collected cohort of patients with SAH was performed. Rebleeding was diagnosed as new or expanded hemorrhage on CT, which was determined by independent review conducted by multiple physicians. Preventability of rebleeding by ultra-early aneurysm clipping or coiling was also independently reviewed. Standard statistics were used to determine statistically significant differences between the demographic characteristics of those with rebleeding compared with those without.RESULTSOf 317 patients with aneurysmal SAH, 24 (7.6%, 95% CI 4.7–10.5) experienced rebleeding at any time point following initial aneurysm rupture. Only 1/24 (4.2%, 95% CI −3.8 to 12.2) incidents of rebleeding could have been prevented by a 24-hour ultra-early aneurysm repair protocol. The other 23 incidents could not have been prevented for the following reasons: rebleeding prior to admission to the authors’ institution (14/23, 60.9%); initial diagnostic angiography negative for aneurysm (4/23, 17.4%); postoperative rebleeding (2/23, 8.7%); patient unable to undergo operation due to medical instability (2/23, 8.7%); intraoperative rebleeding (1/23, 4.3%).CONCLUSIONSAt a single tertiary academic center, the overall rebleeding rate was 7.6% (95% CI 4.7–10.5) for those presenting with ruptured aneurysms. Implementation of a 24-hour ultra-early aneurysm repair protocol would only result in, at most, a 0.3% (95% CI −0.3 to 0.9) reduction in the incidence of rebleeding.

scholarly journals Preventive Effect of Clazosentan against Cerebral Vasospasm after Clipping Surgery for Aneurysmal Subarachnoid Hemorrhage in Japanese and Korean Patients

2017 ◽  
Vol 44 (1-2) ◽  
pp. 59-67 ◽  
Author(s):  
Miki Fujimura ◽  
Jin-Yang Joo ◽  
Jong-Soo Kim ◽  
Motonori Hatta ◽  
Yoshinari Yokoyama ◽  
...  
Keyword(s):  
Placebo Group ◽  
Subarachnoid Hemorrhage ◽  
Cerebral Infarction ◽  
Cerebral Vasospasm ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Study Drug ◽  
Aneurysm Rupture ◽  
Dose Finding ◽  
Double Blind ◽  
Korean Patients

Background: Clazosentan has been explored worldwide for the prophylaxis of cerebral vasospasm after aneurysmal subarachnoid hemorrhage (aSAH). In a dose-finding trial (CONSCIOUS-1) conducted in Israel, Europe, and North America, clazosentan (1, 5, and 15 mg/h) significantly reduced the incidence of cerebral vasospasm, but its efficacy in Japanese and Korean patients was unknown. We conducted a double-blind comparative study to evaluate the occurrence of cerebral vasospasm in Japanese and Korean patients with aSAH. Methods: The aim of this multicenter, double-blind, randomized, placebo-controlled, dose-finding phase 2 clinical trial, was to evaluate the efficacy, pharmacokinetics, and safety of clazosentan (5 and 10 mg/h) against cerebral vasospasm after clipping surgery in Japanese and Korean patients with aSAH. Patients aged between 20 and 75 years were administered the study drug within 56 h after the aneurysm rupture and up to day 14 post-aSAH. The incidence of vasospasm, defined as an inner artery diameter reduction of major intracranial arteries ≥34% based on catheter angiography, was compared between each treatment group. Cerebral infarction due to vasospasm at 6 weeks and patients' outcome at 3 months was also compared. Results: Among 181 enrolled patients, 158 completed the study and were analyzed. The incidence of vasospasm up to day 14 after aSAH onset was 80.0% in the placebo group (95% CI 67.0-89.6), 38.5% in the 5 mg/h clazosentan group (95% CI 25.3-53.0), and 35.3% in the 10 mg/h clazosentan group (95% CI 22.4-49.9), indicating that the incidence of vasospasm was significantly reduced by clazosentan treatment (placebo vs. 5 mg/h clazosentan, p < 0.0001; placebo vs. 10 mg/h clazosentan, p < 0.0001). The occurrence of cerebral infarction due to vasospasm was 20.8% in the placebo group (95% CI 10.8-34.1), 3.8% in the 5 mg/h clazosentan group (95% CI 0.5-13.2), and 4.2% in the 10 mg/h clazosentan group (95% CI 0.5-14.3), indicating that clazosentan significantly reduced the occurrence of cerebral infarctions caused by vasospasm (placebo vs. 5 mg/h clazosentan, p = 0.0151; placebo vs. 10 mg/h clazosentan, p = 0.0165). The overall incidence of all-cause death and/or vasospasm-related morbidity/mortality was significantly reduced in the 10 mg/h clazosentan group compared with the placebo group (p = 0.0003). Conclusion: These results suggest that clazosentan prevents cerebral vasospasm and subsequent cerebral infarction, and could thereby improve outcomes after performing a clipping surgery for aSAH in Japanese and Korean patients.

Effect of Cilostazol on Cerebral Vasospasm and Outcome in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized, Double-Blind, Placebo-Controlled Trial

2016 ◽  
Vol 42 (1-2) ◽  
pp. 97-105 ◽  
Author(s):  
Naoya Matsuda ◽  
Masato Naraoka ◽  
Hiroki Ohkuma ◽  
Norihito Shimamura ◽  
Katsuhiro Ito ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Cerebral Infarction ◽  
Cerebral Vasospasm ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Control Group ◽  
Independent Factor ◽  
Double Blind ◽  
End Points ◽  
Double Blind Placebo ◽  
Poor Outcome

Background: Several clinical studies have indicated the efficacy of cilostazol, a selective inhibitor of phosphodiesterase 3, in preventing cerebral vasospasm after aneurysmal subarachnoid hemorrhage (SAH). They were not double-blinded trial resulting in disunited results on assessment of end points among the studies. The randomized, double-blind, placebo-controlled study was performed to assess the effectiveness of cilostazol on cerebral vasospasm. Methods: Patients with aneurysmal SAH admitted within 24 h after the ictus who met the following criteria were enrolled in this study: SAH on CT scan was diffuse thick, diffuse thin, or local thick, Hunt and Hess score was less than 4, administration of cilostazol or placebo could be started within 48 h of SAH. Patients were randomly allocated to placebo or cilostazol after repair of a ruptured saccular aneurysm by aneurysmal neck clipping or endovascular coiling, and the administration of cilostazol or placebo was continued up to 14 days after initiation of treatment. The primary end point was the occurrence of symptomatic vasospasm (sVS), and secondary end points were angiographic vasospasm (aVS) evaluated on digital subtraction angiography, vasospasm-related new cerebral infarction evaluated on CT scan or MRI, and clinical outcome at 3 months of SAH as assessed by Glasgow Outcome Scale, in which poor outcome was defined as severe disability, vegetative state, and death. All end points were evaluated with blinded assessment. Results: One hundred forty eight patients were randomly allocated to the cilostazol group (n = 74) or the control group (n = 74). The occurrence of sVS was significantly lower in the cilostazol group than in the control group (10.8 vs. 24.3%, p = 0.031), and multiple logistic analysis showed that cilostazol use was an independent factor reducing sVS (OR 0.293, 95% CI 0.099-0.568, p = 0.027). The incidence of aVS and vasospasm-related cerebral infarction were not significantly different between the groups. Poor outcome was significantly lower in the cilostazol group than in the control group (5.4 vs. 17.6%, p = 0.011), and multiple logistic analyses demonstrated that cilostazol use was an independent factor that reduced the incidence of poor outcome (OR 0.221, 95% CI 0.054-0.903, p = 0.035). Severe adverse events due to cilostazol administration did not occur during the study period. Conclusions: Cilostazol administration is effective in preventing sVS and improving outcomes without severe adverse events. A larger-scale study including more cases was necessary to confirm this efficacy of cilostazol.

Volumetric quantification of aneurysmal subarachnoid hemorrhage independently predicts hydrocephalus and seizures

2021 ◽  
pp. 1-9
Author(s):  
Badih J. Daou ◽  
Siri Sahib S. Khalsa ◽  
Sharath Kumar Anand ◽  
Craig A. Williamson ◽  
Noah S. Cutler ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Characteristic Curve ◽  
Volumetric Analysis ◽  
Aneurysm Rupture ◽  
Mean Difference ◽  
Analysis Tool ◽  
Volume Data ◽  
Hemorrhage Volume ◽  
The Mean

OBJECTIVEHydrocephalus and seizures greatly impact outcomes of patients with aneurysmal subarachnoid hemorrhage (aSAH); however, reliable tools to predict these outcomes are lacking. The authors used a volumetric quantitative analysis tool to evaluate the association of total aSAH volume with the outcomes of shunt-dependent hydrocephalus and seizures.METHODSTotal hemorrhage volume following aneurysm rupture was retrospectively analyzed on presentation CT imaging using a custom semiautomated computer program developed in MATLAB that employs intensity-based k-means clustering to automatically separate blood voxels from other tissues. Volume data were added to a prospectively maintained aSAH database. The association of hemorrhage volume with shunted hydrocephalus and seizures was evaluated through logistic regression analysis and the diagnostic accuracy through analysis of the area under the receiver operating characteristic curve (AUC).RESULTSThe study population comprised 288 consecutive patients with aSAH. The mean total hemorrhage volume was 74.9 ml. Thirty-eight patients (13.2%) developed seizures. The mean hemorrhage volume in patients who developed seizures was significantly higher than that in patients with no seizures (mean difference 17.3 ml, p = 0.01). In multivariate analysis, larger hemorrhage volume on initial CT scan and hemorrhage volume > 50 ml (OR 2.81, p = 0.047, 95% CI 1.03–7.80) were predictive of seizures. Forty-eight patients (17%) developed shunt-dependent hydrocephalus. The mean hemorrhage volume in patients who developed shunt-dependent hydrocephalus was significantly higher than that in patients who did not (mean difference 17.2 ml, p = 0.006). Larger hemorrhage volume and hemorrhage volume > 50 ml (OR 2.45, p = 0.03, 95% CI 1.08–5.54) were predictive of shunt-dependent hydrocephalus. Hemorrhage volume had adequate discrimination for the development of seizures (AUC 0.635) and shunted hydrocephalus (AUC 0.629).CONCLUSIONSHemorrhage volume is an independent predictor of seizures and shunt-dependent hydrocephalus in patients with aSAH. Further evaluation of aSAH quantitative volumetric analysis may complement existing scales used in clinical practice and assist in patient prognostication and management.

Variation of patient characteristics, management, and outcome with timing of surgery for aneurysmal subarachnoid hemorrhage

2011 ◽  
Vol 114 (4) ◽  
pp. 1045-1053 ◽  
Author(s):  
Kelly B. Mahaney ◽  
Michael M. Todd ◽  
James C. Torner
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Management Practices ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Timing Of Surgery ◽  
Early Surgery ◽  
Outcome Variable ◽  
Optimal Time ◽  
World Federation ◽  
Time Interval ◽  
Fisher Grade

ObjectThe past 30 years have seen a shift in the timing of surgery for aneurysmal subarachnoid hemorrhage (SAH). Earlier practices of delayed surgery that were intended to avoid less favorable surgical conditions have been replaced by a trend toward early surgery to minimize the risks associated with rebleeding and vasospasm. Yet, a consensus as to the optimal timing of surgery has not been reached. The authors hypothesized that earlier surgery, performed using contemporary neurosurgical and neuroanesthesia techniques, would be associated with better outcomes when using contemporary management practices, and sought to define the optimal time interval between SAH and surgery.MethodsData collected as part of the Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) were analyzed to investigate the relationship between timing of surgery and outcome at 3 months post-SAH. The IHAST enrolled 1001 patients in 30 neurosurgical centers between February 2000 and April 2003. All patients had a radiographically confirmed SAH, were World Federation of Neurosurgical Societies Grades I–III at the time of surgery, and underwent surgical clipping of the presumed culprit aneurysm within 14 days of the date of hemorrhage. Patients were seen at 90-day follow-up visits. The primary outcome variable was a Glasgow Outcome Scale score of 1 (good outcome). Intergroup differences in baseline, intraoperative, and postoperative variables were compared using the Fisher exact tests. Variables reported as means were compared with ANOVA. Multiple logistic regression was used for multivariate analysis, adjusting for covariates. A p value of less than 0.05 was considered to be significant.ResultsPatients who underwent surgery on Days 1 or 2 (early) or Days 7–14 (late) (Day 0 = date of SAH) fared better than patients who underwent surgery on Days 3–6 (intermediate). Specifically, the worst outcomes were observed in patients who underwent surgery on Days 3 and 4. Patients who had hydrocephalus or Fisher Grade 3 or 4 on admission head CT scans had better outcomes with early surgery than with intermediate or late surgery.ConclusionsEarly surgery, in good-grade patients within 48 hours of SAH, is associated with better outcomes than surgery performed in the 3- to 6-day posthemorrhage interval. Surgical treatment for aneurysmal SAH may be more hazardous during the 3- to 6-day interval, but this should be weighed against the risk of rebleeding.

Abstract P823: Evaluating Time-To-Aneurysm Repair as a Performance Measure in Aneurysmal Subarachnoid Hemorrhage

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Tiffany O Sheehan ◽  
Nicolle W Davis ◽  
Yi Guo ◽  
Debra Lynch Kelly ◽  
Saun-joo Yoon ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Performance Metrics ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Patient Characteristics ◽  
Performance Measure ◽  
Hospital Death ◽  
Discharge Data ◽  
Stroke Center ◽  
Aneurysm Repair ◽  
The Relationship

Background: Implementation of evidence-based performance metrics drive standardized care and improve patient outcomes. Limited performance metrics have been developed for implementation in the aneurysmal subarachnoid hemorrhage (aSAH) population. Timely aneurysm repair following an aSAH is associated with rebleeding prevention and mortality. The purpose of this study was to evaluate time to aneurysm repair as a candidate performance metric by testing a model that includes hospital and patient characteristics as predictors of time to aneurysm repair and mortality, with time to aneurysm repair as a potential influence on these relationships in aSAH. Methods: A retrospective, cross-sectional analysis of patient discharge data from 2014 in the state of Florida was conducted. Data were derived from The Agency for Healthcare Research and Quality, HealthCare Utilization Project, State Inpatient Dataset, and the American Hospital Association Annual Survey. Patients with a primary ICD-9 diagnosis of aSAH and principle procedure of clipping or coiling were included (n=387). The study outcome was in-hospital mortality. Independent variables were level of stroke center, age, race, sex, and type of aneurysm repair. Hierarchical logistic regression was used to estimate the probability of in-hospital death. Results: Patients who underwent endovascular repair of an aneurysm were more likely to be treated in <24 hours compared to those undergoing aneurysm clipping (OR = 0.54, CI = .35-.84, p =0.01). Patients treated at a comprehensive stroke center (CSC) had a 72% reduction in odds of death compared to those treated at primary stroke centers (OR =0.28, CI = 0.10-0.77, p =0.01), controlling for disease severity and comorbidity. Time to aneurysm repair was not significantly associated with mortality and did not influence the relationship between hospital and patient characteristics and mortality. Conclusions: Treatment at a certified CSC was the only significant predictor of surviving aSAH. Time to aneurysm repair did not influence the relationship between hospital and patient characteristics associated with mortality. Further research is needed to identify appropriate measures and to define what should be tracked for performance in the aSAH population.

Abstract T P352: Dantrolene for the Prevention and Treatment of Cerebral Vasospasm after Subarachnoid Hemorrhage - A Randomized Placebo-Controlled Trial to Assess Safety, Tolerability and Feasibility

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Susanne Muehlschlegel ◽  
Raphael Carandang ◽  
Wiley Hall ◽  
Kini Nisha ◽  
Saef Izzy ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Cerebral Vasospasm ◽  
Liver Toxicity ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Delayed Cerebral Ischemia ◽  
Double Blind ◽  
Outcome Differences ◽  
Infusion Period

Introduction: Dantrolene is neuroprotective in animal models and may attenuate cerebral vasospasm (cVSP) after aneurysmal subarachnoid hemorrhage (aSAH) in humans. We evaluated safety/tolerability and feasibility of intravenous dantrolene (IV-D) after aSAH. Methods: In this single-center, randomized, double-blind, placebo-controlled trial, 31 patients with acute aSAH were randomized to IV-D 1.25 mg IV every 6 hours x 7 days (n=16) or placebo (n=15). Primary endpoint was incidence of hyponatremia (sNa ≤ 134 mmol/L) and liver toxicity (% patients with ALT, AST and AlkPhos >5x upper limit of normal). Secondary safety endpoints included tolerability, systemic hypotension and intracranial hypertension. Efficacy was explored by clinical, transcranial Doppler (TCD) or angiographic cVSP occurrence, delayed cerebral ischemia (DCI) and 3-month modified-Rankin-Scale, Glasgow Outcome Scale and Barthel Index. Statistical analysis was performed using non-parametric tests, generalized estimating equations and mixed models. Results: Between IV-D vs. placebo, no differences were observed in the primary outcome (hyponatremia: 44% vs. 67% [p=0.29]; liver toxicity 6% vs. 0% [p=1.0]). Numerically more AEs and SAEs were seen in the IV-D group, but did not reach statistical significance (16 vs. 5 AEs, of which 5 vs. 2 were severe; RR 2.2; 95% CI 0.7-6.7; p=0.16). Three IV-D vs. two placebo patients reached stop criteria: one IV-D patient developed liver toxicity; two patients in each group developed brain edema requiring osmotherapy. No differences in angiographic, TCD, clinical cVSP, DCI, or 3-month functional outcomes were seen. Quantitative angiogram analysis revealed a trend towards increased vessel diameters in the IV-D group after the 7-day infusion-period (p=0.05). Conclusion: In this small trial, IV-Dantrolene after aSAH was feasible, tolerable and safe, but was underpowered to show efficacy or outcome differences.

scholarly journals Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Peter Y. M. Woo ◽  
Joanna W. K. Ho ◽  
Natalie M. W. Ko ◽  
Ronald P. T. Li ◽  
Leo Jian ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Adverse Effects ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Pilot Trial ◽  
Delayed Cerebral Ischemia ◽  
Trial Registration ◽  
Study Group ◽  
Double Blind ◽  
Link Type ◽  
Significant Difference

Asbtract Background There are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). Cerebrolysin, a brain-specific proposed pleiotropic neuroprotective agent, has been suggested to improve global functional outcomes in ischemic stroke. We investigated the efficacy, safety and feasibility of administering Cerebrolysin for SAH patients. Methods This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study. Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group). The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months. Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI). Results No severe adverse effects or mortality attributable to Cerebrolysin were observed. No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43–5.17). Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79–15.01) were comparable for both groups. Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28–2.59). Conclusions Use of Cerebrolysin in addition to standard-of-care management of aneurysmal SAH is safe, well tolerated and feasible. However, the neutral results of this trial suggest that it does not improve the six-month global functional performance of patients. Clinical trial registration Name of Registry: ClinicalTrials.gov Trial Registration Number: NCT01787123. Date of Registration: 8th February 2013.

No effect of enoxaparin on outcome of aneurysmal subarachnoid hemorrhage: a randomized, double-blind, placebo-controlled clinical trial

2003 ◽  
Vol 99 (6) ◽  
pp. 953-959 ◽  
Author(s):  
Jari Siironen ◽  
Seppo Juvela ◽  
Joona Varis ◽  
Matti Porras ◽  
Kristiina Poussa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Molecular Weight ◽  
Subarachnoid Hemorrhage ◽  
Low Molecular Weight Heparin ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Intracranial Bleeding ◽  
Low Molecular Weight ◽  
Double Blind ◽  
Content Type ◽  
Fine Print

Object. From the moment an intracranial aneurysm ruptures, cerebral blood flow is impaired, and this impairment mainly determines the outcome in patients who survive after the initial bleeding. The exact mechanism of impairment is unknown, but activation of coagulation and fibrinolysis correlate with clinical condition and outcome after aneurysmal subarachnoid hemorrhage (SAH). The purpose of this study was to determine whether enoxaparin, a low-molecular-weight heparin, which is a well-known anticoagulating agent, has any effect on the outcome of aneurysmal SAH postoperatively. Methods. In this randomized, double-blind, single-center clinical trial, 170 patients (85 per group) with aneurysmal SAH were randomly assigned to receive either enoxaparin (40 mg subcutaneously once daily) or a placebo, starting within 24 hours after occlusion of the aneurysm and continuing for 10 days. Analysis was done on an intention-to-treat basis. Outcome was assessed at 3 months on both the Glasgow Outcome and modified Rankin Scales. Patients were eligible for the study if surgery was performed within 48 hours post-SAH, and no intracerebral hemorrhage was larger than 20 mm in diameter on the first postoperative computerized tomography scan. At 3 months, there were no significant differences in outcome by treatment group. Of the 170 patients, 11 (6%) died, and only 95 (56%) had a good outcome. Principal causes of unfavorable outcome were poor initial condition, delayed cerebral ischemia, and surgical complications. There were four patients with additional intracranial bleeding in the group receiving enoxaparin. The bleeding was not necessarily associated with the treatment itself, nor did it require treatment, and there were no such patients in the placebo group. Conclusions. Enoxaparin seemed to have no effect on the outcome of aneurysmal SAH in patients who had already received routine nimodipine and who had received triple-H therapy when needed. Routine use of low-molecular-weight heparin should be avoided during the early postoperative period in patients with SAH, because this agent seems to increase intracranial bleeding complications slightly, with no beneficial effect on neurological outcome.

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