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

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.

Study Overview

• Status: Completed
• Conditions: Intra Cerebral Hemorrhage
• Intervention / Treatment: Other: Phone interview

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A tertiary medical center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICH; Patients were eligible for inclusion if they; were aged 20 years or older; had been admitted to a neurology, neurosurgery, or rehabilitation ward with a diagnosis of primary ICH; had a diagnosis of ICH confirmed by a brain CT; have written informed consent given by themselves or by their legal representative	Other: Phone interview; A interview follow-up with a physician by phone was performed at 12 months after the onset of ICH.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Mingyen Hsiao, MD, phD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Prognosis; Survivors; Functional outcome; Intracerebral hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 201905045RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No