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CompletedNCT06824311Updated Feb 14, 2025

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

An observational study in Hemorrhage, Intracranial and Outcome Measure, sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine.. Completed at 1 site in Nepal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
197
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hemorrhage, Intracranial
  • Outcome Measure

Keywords

  • hemorrhagic stroke
  • spontaneous intracerebral hemorrhage
  • mRS scale
  • functional outcome after stroke
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In context

Hemorrhagic Stroke

214 studies on the registry are indexed under Hemorrhagic Stroke; 84 are open to participants now.

This study's enrollment of 197 is below the median of 300 across 64 observational studies indexed under Hemorrhagic Stroke.

Browse Hemorrhagic Stroke studies →

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine. is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

  • Diagnosed case of hemorrhagic stroke

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
197 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Modified Rankin Scale at 3 months

    Time frame: From the diagnosis of hemorrhagic stroke to 3 months of follow up

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Study locations

1 site
  • Tribhuvan University Teaching Hospital
    Maharajgunj, Bagmati 9771, Nepal
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References and documents

Publications

  • 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. PubMed 22691158 ↗
  • 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. PubMed 34986727 ↗
  • 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. PubMed 29791947 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06824311
Lead sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Responsible party
Sumit Shahi (Resident, Department of Neurology, Principal Investigator, Tribhuvan University Teaching Hospital, Institute Of Medicine.) — Principal investigator
First posted
Feb 13, 2025
Start date
Apr 1, 2023
Primary completion
Mar 31, 2024
Completion
Jun 30, 2024
Last update
Feb 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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