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

February 12, 2025 updated by: Sumit Shahi, Tribhuvan University Teaching Hospital, Institute Of Medicine.
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Maharajgunj, Bagmati, Nepal, 9771
        • Tribhuvan University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted in neurology department of Tribhuvan University Teaching Hospital with diagnosis of hemorrhagic stroke

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin Scale at 3 months
Time Frame: From the diagnosis of hemorrhagic stroke to 3 months of follow up
From the diagnosis of hemorrhagic stroke to 3 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 437 (6-11) E2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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