Validation of the ICH Score for the Prediction of 12-month Functional Outcome in Patients With Primary Intracerebral Hemorrhage

Completed

• Conditions: Intra Cerebral Hemorrhage
• Interventions: Other: Phone interview

• Registration Number: NCT05808777
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The goal of this observational study is to analyze the validity of the intracerebral hemorrhage (ICH) Score and a new modified ICH score for the prediction of 12-month functional outcome in patients with primary ICH.

Participants who were admitted to NTUH rehabilitation ward will be followed up to 12 months after the onset of ICH. The follow-up will be conducted by phone interviews.

Detailed Description

The ICH Score had been utilized to predict the 30-day mortality after acute intracerebral hemorrhage (ICH), but there's still no reliable tool in predicting the long-term functional outcome in ICH patients. Recently, there have been some studies that use ICH score to predict the prognosis of functional outcome in ICH patients. However, most studies included patients in western societies. Relevant studies in Taiwan were scarce. The present study will follow up the patients with ICH, who were admitted to NTUH rehabilitation ward, up to 12 months post stroke. The follow-up will be conducted by phone interviews at certain time after the onset of ICH. Investigators aim to analyze the validity of the ICH Score for the prediction of 12-month functional outcome in patients with primary ICH. Investigators will also add other variables to see if the revised score could better predict the prognosis among ICH patients.

Study Timeline

• Study Start: 2019-06-24
• Primary Completion: 2022-06-23
• Study Completion: 2022-06-23
• Status Verified: 2023-03
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-09
• Last Update Submitted: 2023-04-09
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged 20 years or older
• Had been admitted to a neurology, neurosurgery, or rehabilitation ward with a diagnosis of primary intracerebral hemorrhage (ICH)
• Had a diagnosis of ICH confirmed by a brain computed tomography (CT)
• Have written informed consent given by themselves or by their legal representative

Exclusion Criteria

• ICH related to aneurysm, arteriovenous malformation, or trauma
• Died before discharge

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICH	Phone interview	Patients were eligible for inclusion if they 1. were aged 20 years or older 2. had been admitted to a neurology, neurosurgery, or rehabilitation ward with a diagnosis of primary ICH 3. had a diagnosis of ICH confirmed by a brain CT 4. have written informed consent given by themselves or by their legal representative

Primary Outcome Measures

Name	Time	Method
Barthel index	12-month after ICH onset	Barthel index score, range: 0-100, higher scores mean a better outcome
Modified Rankin scale	12-month after ICH onset	Modified Rankin scale, range: 0-6, higher scores mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
Rehabilitation treatment course	12-month after ICH onset	Including inpatient rehabilitation and outpatient rehabilitation
Tube retention rate	12-month after ICH onset	Including Nasogastric (NG) tube, Foley catheter, tracheal tube

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan