Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.

Study Overview
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Brief Summary
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The ideal management of blood pressure in BP after acute intracerebral haemorrhage is still debated and whether a higher intensive reduction of blood pressure after acute intracerebral haemorrhage may be better or not is still controversial. Conflicting results from different randomized trials in regards to the clinical guidelines for management of hypertension in people with acute intracerebral hemorrhage (ICH). These results indicate that the management of BP and the prognosis after acute spontaneous ICH are very complicated. Therefore, analysis based on actual blood pressure (BP) accomplished may be a more efficient method to assess the impact of BP management on outcome of ICH. In our research, blood pressure (BP) management and prognosis were studied in patients with acute intracerebral hemorrhage to decide the perfect time control BP to improve outcome.

Detailed Description
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Methods: Patients were diagnosed by clinical examination and according to the initial CT brain after the onset of ICH. Intensive management of blood pressure (BP) started once the diagnosis of intracerebral hemorrhage was established. Systolic blood pressure targeted 140 mm Hg by IV drug that lower BP like nicardipine or diltiazem. Oral antihypertensive medications like (Angiotensin II Receptor Blockers (ARBs) or Ca-blocker), after 24 h of hospitalization, was utilized in combination and step by step changed from intravenous administration. Patients were exposed to: A) Complete history taking and complete clinical assessment including neurological and general examinations. B) Initial Glasgow Coma Scale score at admission to hospital and patients according to GCS score were classified to 3 groups I (13-15), II (5-12), and III (3-4 ) according to Hemphill et al 2001. C-Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to six]. D- Routine laboratory examinations including CBC, blood sugar, coagulation tests, renal and hepatic functions. E- CT brain was accomplished for all patients at onset of admission to hospital to decide the characters of spontaneous intracerebral hemorrhage (ICH). The volume of the intracerebral hemorrhage was determined utilizing the ABC/2 method (A is the most great diameter on the most large ICH cut, B is the diameter perpendicular to A, while, C is the number of axial cuts of ICH multiplied by the thickness of cuts. Additionally, the location ICH (regardless of whether infra or supatrentorial), and if there is IVH or not, also, if there is shift of midline structure or hydrocephalic changes were determined. Regarding ICH volume, patients were partitioned into two groups (< 30 cm3 and ≥30 cm3). Statistical analysis SPSS version 19.0 was utilized for statistical analysis. Data were collected and displayed as numbers proportions, mean ± standard deviation, and range. Favorable and unfavorable groups were compared by chi-square measurement. For variable with ordinary distributions and homogeneous variances, Student's t-test was utilized to check the significant difference between the mean ± standard deviation values in the two groups. P value <0.05 were considered of statistical significant results. Multivariate logistic regression analysis was accomplished for the independent variables or factors that were accompanied by better outcomes: like younger ages, GCS at admission, diastolic blood pressure one hour after admission, systolic BP 6 h after admission, and systolic blood pressure 24 h after admission.

Official Title
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Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.

Conditions
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Intra Cerebral Hemorrhage, Hypertension

Intervention / Treatment
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* Diagnostic Test: Modified Rankin Scale (mRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients incorporated into this study aged over 25 years of either sex with first spontaneous intracerebral hemorrhage (ICH). Exclusion Criteria: Secondary ICH were excluded from this study (like traumatic, hemorrhagic infarcts, AVM, bleeding tumors or SOL, or IVH only without ICH). Patients with previous ischemic stroke or T1As

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Unfavorable outcome<br>80 patients with poor outcome were classified according to mRS score after discharge (mRS range from 3 up to 6). | Diagnostic Test: Modified Rankin Scale (mRS)<br>* Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to six<br>|
| Favorable outcome<br>70 patients with better outcome were classified according to mRS score after discharge (mRS range from 0 up to 2) . | Diagnostic Test: Modified Rankin Scale (mRS)<br>* Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to six<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma Scale score | Initial Glasgow Coma Scale score at admission to hospital and patients according to GCS score were classified to 3 groups I (13-15), II (5-12), and III (3-4 ) according to Hemphill et al 2001. | 24 hours | 
| CT brain | CT brain was accomplished for all patients at onset of admission to hospital to decide the characters of spontaneous intracerebral hemorrhage (ICH). The volume of the intracerebral hemorrhage was determined utilizing the ABC/2 method (A is the most great diameter on the most large ICH cut, B is the diameter perpendicular to A, while, C is the number of axial cuts of ICH multiplied by the thickness of cuts. Additionally, the location ICH (regardless of whether infra or supatrentorial), and if there is IVH or not, also, if there is shift of midline structure or hydrocephalic changes were determined. Regarding ICH volume, patients were partitioned into two groups (< 30 cm3 and ≥30 cm3) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) | Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging fModified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to six rom zero up to two, while unfavorable outcome ranging for 3 up to six | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICH, Hypertension, GCS , and mRS.