Clinical trial NCT06824311: Clinical Characteristics and Outcome of Patients with Hemorrhagic Stroke Admitted in Neurology Department in a Tertiary Hospital
Official title: Clinical Characteristics and Outcome of Patients with Hemorrhagic Stroke Admitted in Neurology Department in a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage, Intracranial
Outcome Measure
Keywords: hemorrhagic stroke
spontaneous intracerebral hemorrhage
mRS scale
functional outcome after stroke
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in neurology department of Tribhuvan University Teaching Hospital with diagnosis of hemorrhagic stroke

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale at 3 months
timeFrame: From the diagnosis of hemorrhagic stroke to 3 months of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Maharajgunj
country: Nepal
facility: Tribhuvan University Teaching Hospital
state: Bagmati
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.