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

NCT ID: NCT05808777

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2022-06-23

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.

Conditions

Intra Cerebral Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICH

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

Phone interview

Intervention Type: OTHER

A interview follow-up with a physician by phone was performed at 12 months after the onset of ICH.

Interventions

Phone interview

A interview follow-up with a physician by phone was performed at 12 months after the onset of ICH.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingyen Hsiao, MD, phD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201905045RINB

Identifier Type: -

Identifier Source: org_study_id