Impact of stereotactic hematoma evacuation on activities of daily living during the chronic period following spontaneous putaminal hemorrhage: a randomized study

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Object. Stereotactic evacuation of hematoma has been reported to reduce the incidence of mortality and to improve functional outcome in patients with spontaneous putaminal hemorrhage. Stereotactic evacuation of hematoma has not been widely accepted as a standard therapy, however, because its effect on functional outcome has been regarded as marginal and there have been no randomized trials with sufficient statistical power to quantify the benefits of this procedure. The authors reassessed the value of stereotactic evacuation of hematoma by analyzing its impact on activities of living during the chronic period following spontaneous putaminal hemorrhage in a randomized study.

Methods. Four hundred ninety patients were entered into the study. The severity of their hemorrhages was graded neurologically on admission (neurological grades: 1, eyes are open; 2, eyes are closed but open to weak stimuli; 3, eyes are closed but open to strong stimuli; 4, eyes do not open but extremities move to stimuli; and 5, eyes do not open and extremities do not move to stimuli). Patients with Grade 2 and those with Grade 3 were randomized into two groups with different treatment protocols (Group I, stereotactic evacuation of the hematoma; and Group II, conservative treatment). Patients assigned neurological Grade 4 or 5 were excluded from the study because a large-scale retrospective study in Japan revealed that surgical treatment in patients assigned to these neurological grades does not improve functional outcome. Among the 490 patients, 242 were randomized strictly. This patient population comprised 148 men and 94 women ranging in age from 38 to 80 years (mean 60.5 years).

Compared with Group II, Group I treatment resulted in a lower mortality rate and better recovery to functional independence in patients with neurological Grade 3. In patients with Grade 2, Group I treatment contributed to a better recovery of functional outcome and a lower mortality rate, but the difference was not significant. Multivariate analysis confirmed that stereotactic evacuation of the hematoma was contributory to a better recovery in functional outcome.

Conclusions. Stereotactic evacuation of hematoma is clearly of value in selected patients with spontaneous putuminal hemorrhage, whose eyes are closed but will open in response to strong stimuli (neurological Grade 3) on admission.

Abstract

Object. Stereotactic evacuation of hematoma has been reported to reduce the incidence of mortality and to improve functional outcome in patients with spontaneous putaminal hemorrhage. Stereotactic evacuation of hematoma has not been widely accepted as a standard therapy, however, because its effect on functional outcome has been regarded as marginal and there have been no randomized trials with sufficient statistical power to quantify the benefits of this procedure. The authors reassessed the value of stereotactic evacuation of hematoma by analyzing its impact on activities of living during the chronic period following spontaneous putaminal hemorrhage in a randomized study.

Methods. Four hundred ninety patients were entered into the study. The severity of their hemorrhages was graded neurologically on admission (neurological grades: 1, eyes are open; 2, eyes are closed but open to weak stimuli; 3, eyes are closed but open to strong stimuli; 4, eyes do not open but extremities move to stimuli; and 5, eyes do not open and extremities do not move to stimuli). Patients with Grade 2 and those with Grade 3 were randomized into two groups with different treatment protocols (Group I, stereotactic evacuation of the hematoma; and Group II, conservative treatment). Patients assigned neurological Grade 4 or 5 were excluded from the study because a large-scale retrospective study in Japan revealed that surgical treatment in patients assigned to these neurological grades does not improve functional outcome. Among the 490 patients, 242 were randomized strictly. This patient population comprised 148 men and 94 women ranging in age from 38 to 80 years (mean 60.5 years).

Compared with Group II, Group I treatment resulted in a lower mortality rate and better recovery to functional independence in patients with neurological Grade 3. In patients with Grade 2, Group I treatment contributed to a better recovery of functional outcome and a lower mortality rate, but the difference was not significant. Multivariate analysis confirmed that stereotactic evacuation of the hematoma was contributory to a better recovery in functional outcome.

Conclusions. Stereotactic evacuation of hematoma is clearly of value in selected patients with spontaneous putuminal hemorrhage, whose eyes are closed but will open in response to strong stimuli (neurological Grade 3) on admission.

Spontaneous ICH produces serious neurological sequelae,4,8–12,15,18,27,30,32,39 which require long-term medical and social care, imposing heavy financial and mental burdens on patients and their families and causing an enormous loss to society. At present, there is no consensus on treatment of patients with ICH because to date there has been no randomized study demonstrating an improvement in functional outcome and mortality rates following surgical intervention compared with medical treatment. All previous trials were individually insufficient in their statistical power to be used reliably to quantify the risks and benefits of surgery.

Stereotactic evacuation of hematoma has been reported to reduce the incidence of mortality and improve functional outcomes in patients with spontaneous ICH, especially in those with hemorrhage within the putamen.1,3,5–7,13,14,16,19–22,24–26,33,34,37,38 Stereotactic evacuation of hematoma has not been widely accepted as a standard therapy for treating spontaneous ICH, however, because its effect on functional outcome has been regarded as marginal and there has been no randomized trial of this procedure. We therefore conducted our original randomized trial in patients with putaminal hemorrhage in an attempt to evaluate the effectiveness of stereotactic evacuation of hematoma.

Clinical Material and Methods

In this prospective study, we examined 490 patients in whom spontaneous putaminal hemorrhage was diagnosed on the basis of findings on CT scans. The patients were hospitalized at five hospitals affiliated with our department during the 3-year period between 1998 and 2000. The following inclusion criteria were used for the study: 1) patient age between 35 and 85 years; and 2) an interval between stroke and the start of treatment lasting less than 24 hours. The following exclusion criteria were included: 1) patients in whom hemorrhage spread into brain tumors or came from cerebral aneurysms or arteriovenous malformations; 2) patients with malignant neoplasms; and 3) patients with bleeding disorders or those receiving anticoagulant medications.

Neurological Grading and CT Classification

The severity of the neurological injury was defined on admission according to the neurological grades adopted by the Japanese Cooperative Study on Stroke Surgery19 (Grade 1, eyes are open; Grade 2, eyes are closed but open to weak stimuli; Grade 3, eyes are closed but open to strong stimuli; Grade 4, eyes do not open but extremities move in response to stimuli without [4a] or with [4b] signs of herniation; and Grade 5, eyes do not open and extremities do not move in response to stimuli). Findings on CT scans were categorized into five groups, regardless of whether there was intra ventricular hemorrhage, according to the classification adopted by the Japanese Cooperative Study on Stroke Surgery (Grade I, localized in the putamen and outside the internal capsule; Grade II, extending to the anterior limb of the internal capsule; Grade III, extending to the posterior limb of the internal capsule; Grade IV, extending to the anterior and posterior limbs of the internal capsule; and Grade V, extending to the thalamus or subthalamus). The hematoma volume was expressed in cubic centimeters and derived using the formula π width × length × height (cm)/6, based on the length of the hematoma radius estimated on CT scans. Data from laboratory examinations of blood samples obtained on the day of hospital admission were also analyzed.

Randomization of the Treatment Protocol

Patients with neurological Grade 2 or 3 who fulfilled the inclusion criteria were admitted into the study. Randomization was accomplished using sealed, opaque envelopes with equal treatment allocation probabilities (Group I, stereotactic evacuation of the hematoma; Group II, conservative treatment). We explained to the patients and their families the purpose of the present study and informed them that there is no firm evidence to indicate that surgical treatment improves functional outcome. If any patient or family member requested a specific treatment protocol, the patient was excluded from the study. Patients with neurological Grade 1, 4, or 5 were excluded from the study. Patients with neurological Grade 1 were automatically allocated to conservative treatment because there has been no evidence to indicate that surgical treatment improves functional outcome in patients assigned this neurological grade.18 In patients with neurological Grade 4 or 5, we selected each treatment protocol according to the family's requests after we had explained to the family that surgical treatment improves the risk of mortality, but there is no evidence indicating that it improves functional outcome and, even if patients survive, approximately 80% remain severely disabled or in a persistent vegetative state.18 Local ethical committees at each hospital approved the protocol used in this study.

Evaluation of Outcome

Neurological outcome was evaluated directly 1 year posthemorrhage by one of the authors (N.H.) who was blinded to the random allocation. The muscle power of the lower extremity contralateral to the side of hemorrhage was expressed according to the classification of the British Medical Research Council23 (muscle power scores: 1, a trace of contraction; 2, active movement with gravity eliminated; 3, active movement against gravity; 4, active movement against gravity and resistance; and 5, normal power). The ADL were scored by application of the modified Rankin Scale2,29,36 (scores: 0, no symptoms; 1, minor symptoms that do not interfere with lifestyle; 2, minor handicap that leads to some restriction in lifestyle, but does not interfere with the patients' capacity to look after themselves; 3, moderate disability that significantly restricts lifestyle and prevents a totally independent existence; 4, moderately severe disability that clearly prevents an independent existence, although constant attention is not needed; 5, severe disability requiring constant attention night and day; 6, death). The scale was also collapsed into two categories: functional independence (Score 0, 1, or 2) and functional dependence (Score 3, 4, or 5).

Statistical Analysis

Mortality rates and recovery to functional independence were compared between Groups I and II by performing the chi-square test. Costs were compared between these groups by performing the unpaired Student t-test. Differences were regarded as significant if the probability value was less than 0.05. Multiple regression analysis was performed in 120 patients in whom detailed data for the explanatory variables were available. The Spearman correlation coefficient was initially calculated for 21 items including patient age, sex, neurological grading, CT findings, hematoma volume, muscle power, stereotactic evacuation of hematoma, previous cerebrovascular accident, and laboratory data as candidates for explanatory variables of the ADL. The explanatory variables for the multiple regression analysis were then selected. The correlation was regarded as significant if the probability value was less than 0.05.

Results
Effects on ADL

In total, 242 patients were randomized in the present study. There were 148 men and 94 women ranging in age from 38 to 80 years (mean 60.5 years). Among the 242 patients, 121 were surgically treated (Group I) and 121 were treated conservatively (Group II). There were no significant differences between these two groups with regard to age, sex, neurological grading, hematoma volume, side of the hematoma, and history of hypertension (Table 1). Among the patients with neurological Grade 3, those in Group I demonstrated a lower incidence of mortality and better recovery to functional independence than those in Group II. Among the patients with neurological Grade 2, those in Group I had a better recovery of functional outcome and mortality rate, but the differences were not significant (Table 2).

TABLE 1

Characteristics of 242 patients with spontaneous putaminal hemorrhage*

CharacteristicGroup IGroup II
no. of cases121 121 
M/F ratio71:50 77:44 
mean age (yrs)60 ± 10.2 61 ± 8.2 
presence of hypertension65 (53.7%) 70 (57.9%) 
mean hematoma vol (cm3)48 ± 15.6 40 ± 12.3 

Group I patients underwent stereotactic evacuation of the hematoma and Group II patients received conservative treatment. Mean values are given ± standard deviation. No significant difference was noted between the two groups for the listed values.

TABLE 2

Mortality rates and functional outcome in relation to neurological grade and treatment

Functional Outcome (% patients)
Neurological Grade & TreatmentNo. of PatientsMortality Rate (%)IndependentDependent
Grade 2
 Group I704.352.942.9
 Group II7011.440.048.6
Grade 3
 Group I5111.847.141.1*
 Group II5123.521.654.9

p < 0.05 compared with Group II according to the chi-square test.

Among the 21 items analyzed on the Spearman correlation matrix, 12 demonstrated a correlation to the ADL. Of these, hematoma volume showed a strong mutual correlation with CT classification (r = 0.823), neurological grade (r = 0.781), muscle power (r = −0.597), and the number of white blood cells in the blood sample (r = 0.586). The CT classification, neurological grade, and number of white blood cells were therefore excluded from the explanatory variables of the ADL in the multiple regression analysis. In view of the sufficient number of samples and semiquantification for each category, muscle power was incorporated as the dummy variable of the category number unit. Finally, 11 factors including patient age, muscle power 0, muscle power 1, muscle power 2, muscle power 3, muscle power 4, hematoma volume, presence or absence of stereotactic evacuation of hematoma, presence or absence of previous cerebrovascular accident, lactate dehydrogenase level, and cholinesterase level were incorporated as the explanatory variables (Table 3). The regression coefficients were derived, and the multiple correlation coefficient demonstrated statistical significance (r = 0.94).

TABLE 3

Results of multiple regression analysis of ADL

Explanatory VariableRegression Coefficientp Value
patient age0.040<0.002
hematoma vol0.020<0.001
stereotactic evacuation of hematoma−1.023<0.013
previous cerebrovascular accident0.420<0.003
lactate dehydrogenase0.002<0.039
cholinesterase−1.423<0.015
invariable no.−0.186

The multiple regression analysis showed that, besides muscle power, a larger hematoma volume (0.020; p < 0.001), older age (0.04; p < 0.002), and presence of a previous cerebrovascular accident (0.42; p < 0.003) were contributory to a worse ADL score (Table 3). In addition, the presence of stereotactic evacuation of hematoma (−1.023; p < 0.013) and a higher cholinesterase level (−1.423; p < 0.015) were found to contribute to a better ADL score (Table 3). A comparison of actual and estimated values revealed that 108 (90%) of 120 analyzed cases registered a relative difference that was less than 1.28,31,33,35,40

Discussion

Spontaneous ICH is a devastating condition for both patients and their families. At present, there is no consensus regarding whether surgical therapy produces a better outcome than other alternatives. Several studies involving randomized trials have failed to demonstrate any improvement in morbidity and mortality rates after evacuation of the hematoma by craniotomy in patients with spontaneous ICH.3,17,22,24 McKissock, et al.,22 reported the first randomized trial in 1961 in which 180 patients were included. This investigation was conducted during the pre—microneurosurgical and pre—CT era. In studies reported by Juvela,17 Batjer,3 Morgenstern,24 and their colleagues, the numbers of patients (≤ 52 patients) were too small to come to any firm conclusion. Three recent metaanalyses (≤ 249 patients) of published trials of craniotomy for ICH were found to be inconclusive, indicating that more information is needed from randomized studies to determine the role of surgical evacuation of hematomas.13,28,33 On the other hand, a large-scale retrospective study (7010 patients) in Japan has revealed an improvement in mortality and morbidity rates following hematoma evacuation by craniotomy.18

Many investigators have reported the effectiveness of stereotactic evacuation of hematoma. The advantages of this technique are that it can be performed after administration of local anesthesia and it is minimally invasive.6,14,16,21,25,26 Still, there has been no randomized study on the procedure. In one retrospective investigation the authors indicated no significant difference in mortality and morbidity rates between stereotactic evacuation of hematoma and conservative treatment,38 but the number of patients examined (≤ 40 patients) was too small to come to a firm conclusion. Kandel and Peresedov20 and Tanahashi, et al.,34 found that the procedure only improved the mortality rate in patients with severe hemorrhage, similar to the results of craniotomy. In the study reported by Kandel and Peresedov the severity of the neurological injury was stratified into only two groups. In the study reported by Tanahashi, et al., there was a relatively small number of patients with mild and moderate hemorrhage (43 patients who underwent stereotactic evacuation of the hematoma) in which an effect on the morbidity rate could be shown. Clearly, detailed stratification of the severity of the neurological injury with sufficient numbers of patients in each group is necessary to evaluate the effectiveness of stereotactic evacuation of the hematoma. Another large-scale retrospective study (378 patients)21 has demonstrated that this procedure can improve functional outcome in mild and moderate hemorrhage. In that study, the severity of the neurological injury was stratified into five groups.

Conclusions

The results of the present randomized study confirmed the benefits of stereotactic evacuation of hematoma for reducing the incidence of mortality and improving functional outcome in spontaneous putaminal hemorrhage. Stereotactic evacuation of a hematoma reduced the mortality rate and improved functional outcomes in patients with neurological Grade 3. Multivariate analysis also confirmed that stereotactic evacuation of hematoma contributed to improving the ADL.

Stereotactic hematoma evacuation is clearly of value from the medical point of view in selected patients with spontaneous putaminal hemorrhage whose eyes are closed but will open in response to strong stimuli (neurological Grade 3) on admission.

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    Okimura YOno JIwadate Yet al: [Evaluation of CT-guided stereotactic hematoma aspiration in mild cases with putaminal hemorrhage.] No Shinkei Geka 19:6116171991 (Jpn)No Shinkei Geka 19:

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    Portenoy RKLipton RBBerger ARet al: Intracerebral hemorrhage: a model for the prediction of outcome. J Neurol Neurosurg Psychiatry 50:9769791987J Neurol Neurosurg Psychiatry 50:

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    Prasad KBrowman GSrivastava Aet al: Surgery in primary supratentorial intracerebral hematoma: a meta-analysis of randomized trials. Acta Neurol Scand 95:1031101997Acta Neurol Scand 95:

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    Rankin J: Cerebral vascular accidents in patients over the age of 60: II. Prognosis. Scott Med J 2:2002151957Rankin J: Cerebral vascular accidents in patients over the age of 60: II. Prognosis. Scott Med J 2:

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    Sadoshima SSugimori HIrie Ket al: [Functional outcome at 3.2 years after stroke attack in Fukuoka Prefecture.] Japan J Stroke 17:1531591995 (Jpn)Japan J Stroke 17:

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    Takahashi KKuroda KKanaya H: [Prediction of outcome in putaminal hemorrhage.] No To Shinkei 45:7117181993 (Jpn)No To Shinkei 45:

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    Takahashi KKuroda KKanaya H: Prediction of putaminal hemorrhage mortality by logistic regression analysis. Ann Rept Iwate Med Univ Sch Lib Arts & Sci 26:1151241991Ann Rept Iwate Med Univ Sch Lib Arts & Sci 26:

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This study was supported by funds from the Nihon—Oxford Collaborative Stroke Study and a Grant from the Ministry of Health, Labor and Welfare, Japan.

Article Information

Address reprint requests to: Naoyuki Hattori, M.D., Department of Neurological Surgery, Nihon University School of Medicine, Tokyo 173–8610, Japan. email: ykatayam@med.nihon-u.ac.jp.

© AANS, except where prohibited by US copyright law.

Headings

References

1.

Auer LMDeinsberger WNiederkorn Ket al: Endoscopic surgery versus medical treatment for spontaneous intracerebral hematoma: a randomized study. J Neurosurg 70:5305351989J Neurosurg 70:

2.

Bamford JSandercock PAWarlow CPet al: Interobserver agreement for the assessment of handicap in stroke patients. Stroke 20:8281989 (Letter)Stroke 20:

3.

Batjer HHReisch JSAllen BCet al: Failure of surgery to improve outcome in hypertensive putaminal hemorrhage. A prospective randomized trial. Arch Neurol 47:110311061990Arch Neurol 47:

4.

Broderick JPAdams HP JrBarsan Wet al: Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. A statement for healthcare professionals from a special writing group of the stroke council, American Heart Association. Stroke 30:9059151999Stroke 30:

5.

Broderick JPBrott TGDuldner JEet al: Volume of intracerebral hemorrhage. A powerful and easy-to-use predictor of 30-day mortality. Stroke 24:9879931993Stroke 24:

6.

Broseta JGonzalez-Darder JBarcia-Salorio JL: Stereotactic evacuation of intracerebral hematomas. Appl Neurophysiol 45:4434481982Appl Neurophysiol 45:

7.

Doi EMoriwaki HKomai Net al: [Stereotactic evacuation of intracerebral hematomas.] Neurol Med Chir 22:4614671982 (Jpn)Neurol Med Chir 22:

8.

Evers SMAAAment AJHABlaauw G: Economic evaluation in stroke research: a systematic review. Stroke 31:104610532000Stroke 31:

9.

Geddes JMLChamberlain MABonsall M: The Leeds Family Placement Scheme: principles, participants and postscript. Clin Rehabil 5:53641991Clin Rehabil 5:

10.

Geddes JMLClaiden ADChamberlain MAet al: The Leeds Family Placement Scheme: an evaluation of its use as a rehabilitation resource. Clin Rehabil 3:1891971989Clin Rehabil 3:

11.

Gladman JWhynes DLincoln N: Cost comparison of domiciliary and hospital-based stroke rehabilitation. DOMINO study group. Age Ageing 23:2412451994Age Ageing 23:

12.

Gladman JRFLincoln NBBarer DH: A randomised controlled trial of domiciliary and hospital-based rehabilitation for stroke patients after discharge from hospital. J Neurol Neurosurg Psychiatry 56:9609661993J Neurol Neurosurg Psychiatry 56:

13.

Hankey GJHon C: Surgery for primary intracerebral hemorrhage: is it safe and effective? A systematic review of case series and randomized trials. Stroke 28:212621321997Stroke 28:

14.

Higgins ACNashold BS Jr: Stereotactic evacuation of large intracerebral hematoma. Appl Neurophysiol 43:961031980Appl Neurophysiol 43:

15.

Holloway RGBenesch CGRahilly CRet al: A systematic review of cost-effectiveness research of stroke evaluation and treatment. Stroke 30:134013491999Stroke 30:

16.

Hondo HMatsumoto K: [CT-guided stereotactic evacuation of hypertensive and traumatic intracerebral hemorrhage—experiences with 35 cases.] No Shinkei Geka 11:35481983 (Jpn)No Shinkei Geka 11:

17.

Juvela SHeiskanen OPoranen Aet al: The treatment of spontaneous intracerebral hemorrhage. A prospective randomized trial of surgical and conservative treatment. J Neurosurg 70:7557581989J Neurosurg 70:

18.

Kanaya HKuroda K: Development in neurosurgical approaches to hypertensive intracerebral hemorrhageKaufman HH (ed): Intracerebral Hematomas. New York: Raven Press1992197210Intracerebral Hematomas.

19.

Kanaya HYukawa HIto Zet al: Grading and indications for treatment of ICH of basal ganglia (cooperative study in Japan)Pia HWLangmaid CZierski J (eds): Spontaneous Intracerebral Hematomas: Advances in Diagnosis and Therapy. Berlin: Springer-Verlag1980268274Spontaneous Intracerebral Hematomas: Advances in Diagnosis and Therapy.

20.

Kandel EIPeresedov VV: Stereotactic evacuation of spontaneous intracerebral hematomas. J Neurosurg 62:2062131985J Neurosurg 62:

21.

Matsumoto KHondo H: [Surgical indication for hypertensive brain hemorrhage—update]. No To Shinkei 46:1051171994 (Jpn)No To Shinkei 46:

22.

McKissock WRichardson ATaylor J: Primary intracerebral hemorrhage. A controlled trial of surgical and conservative treatment in 180 unselected cases. Lancet 2:2212261961Lancet 2:

23.

Medical Research Council: Aids to the Examination of the Peripheral Nervous System. London: Her Majesty's Stationery Office1976Medical Research Council: Aids to the Examination of the Peripheral Nervous System.

24.

Morgenstern LBFrankowski RFShedden Pet al: Surgical treatment for intracerebral hemorrhage (STICH): a single-center, randomized clinical trial. Neurology 51:135913631998Neurology 51:

25.

Niizuma HShimizu YYonemitsu Tet al: Results of stereotactic aspiration in 175 cases of putaminal hemorrhage. Neurosurgery 24:8148191989Neurosurgery 24:

26.

Okimura YOno JIwadate Yet al: [Evaluation of CT-guided stereotactic hematoma aspiration in mild cases with putaminal hemorrhage.] No Shinkei Geka 19:6116171991 (Jpn)No Shinkei Geka 19:

27.

Portenoy RKLipton RBBerger ARet al: Intracerebral hemorrhage: a model for the prediction of outcome. J Neurol Neurosurg Psychiatry 50:9769791987J Neurol Neurosurg Psychiatry 50:

28.

Prasad KBrowman GSrivastava Aet al: Surgery in primary supratentorial intracerebral hematoma: a meta-analysis of randomized trials. Acta Neurol Scand 95:1031101997Acta Neurol Scand 95:

29.

Rankin J: Cerebral vascular accidents in patients over the age of 60: II. Prognosis. Scott Med J 2:2002151957Rankin J: Cerebral vascular accidents in patients over the age of 60: II. Prognosis. Scott Med J 2:

30.

Sadoshima SSugimori HIrie Ket al: [Functional outcome at 3.2 years after stroke attack in Fukuoka Prefecture.] Japan J Stroke 17:1531591995 (Jpn)Japan J Stroke 17:

31.

Takahashi KKuroda KKanaya H: [Prediction of outcome in putaminal hemorrhage.] No To Shinkei 45:7117181993 (Jpn)No To Shinkei 45:

32.

Takahashi KKuroda KKanaya H: Prediction of putaminal hemorrhage mortality by logistic regression analysis. Ann Rept Iwate Med Univ Sch Lib Arts & Sci 26:1151241991Ann Rept Iwate Med Univ Sch Lib Arts & Sci 26:

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