Clinical Characteristics and Outcome of Patients with Hemorrhagic Stroke Admitted in Neurology Department in a Tertiary Hospital

NCT ID: NCT06824311

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-30

Brief Summary

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The main aim of this study is to know about the clinical profile of patients who are diagnosed as hemorrhagic stroke as well as the factors that affect good and bad outcomes of those patients after 3 months. Patients will be required to follow up in medical OPD of the same institution after 3 months.

Detailed Description

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This was a prospective observational study conducted on 197 patients of ≥ 18 years of age admitted with the diagnosis of hemorrhagic stroke in Tribhuvan University Teaching Hospital, a tertiary hospital in Nepal from April 1 2023 to March 31, 2024. Patients who do not give consent or with post-traumatic hemorrhages, hemorrhagic transformation of an ischemic stroke, or any intracranial hemorrhages other than primary intracranial hemorrhages were excluded from the study. The study protocol and design were reviewed and approved by the Institutional Review Committee of Tribhuvan University Teaching Hospital \[Ref. 437 (6-11) E2\]. Data was collected in a structured proforma.

The primary outcome of this study was to assess the functional outcome of the patients at 3 months of follow-up. The modified Rankin scale (mRS) was assessed in an outpatient setting during the follow-up. If patients did not attend the 3-month follow-up, mRS was assessed by telephone conversation. Clinical outcome was dichotomously categorized as good outcome if mRS was 0-2 and bad outcome if mRS was ≥ 3.

Analysis for categorical data was done by Chi-squared test, Fisher's exact test. Analysis for continuous data was done using either parametric tests like the t-test, or non-parametric tests like the Mann-Whitney U test depending on the distribution of data. Predictors of clinical outcomes were analyzed using multivariate logistic regression.

Conditions

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Hemorrhage, Intracranial Outcome Measure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed case of hemorrhagic stroke

Exclusion Criteria

* Does not give consent
* Post-traumatic hemorrhages, hemorrhagic transformation of an ischemic stroke, or any intracranial hemorrhages other than primary intracranial hemorrhages were excluded from the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role lead

Responsible Party

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Sumit Shahi

Resident, Department of Neurology, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tribhuvan University Teaching Hospital

Maharajgunj, Bagmati, Nepal

Site Status

Countries

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Nepal

References

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Shaik MM, Loo KW, Gan SH. Burden of stroke in Nepal. Int J Stroke. 2012 Aug;7(6):517-20. doi: 10.1111/j.1747-4949.2012.00799.x. Epub 2012 Jun 13.

Reference Type BACKGROUND
PMID: 22691158 (View on PubMed)

Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.

Reference Type BACKGROUND
PMID: 34986727 (View on PubMed)

Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.

Reference Type BACKGROUND
PMID: 29791947 (View on PubMed)

Other Identifiers

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437 (6-11) E2

Identifier Type: -

Identifier Source: org_study_id

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