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

Completed

• Conditions: Hemorrhage, Intracranial; Outcome Measure

• Registration Number: NCT06824311
• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

Brief Summary

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

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 Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30
• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale at 3 months	From the diagnosis of hemorrhagic stroke to 3 months of follow up

Trial Locations

Locations (1)

Tribhuvan University Teaching Hospital; 🇳🇵 Maharajgunj, Bagmati, Nepal