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

NCT05808777 | Completed

• 1 other identifier: 201905045RINB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra Cerebral Hemorrhage

Keywords

Intracerebral hemorrhage; Functional outcome; Prognosis; Survivors; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Tube retention rate

  12-month after ICH onset

• Rehabilitation treatment course

  12-month after ICH onset

Study Arms (1)

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

Other: Phone interview

Interventions

Phone interview OTHER

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

ICH

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A tertiary medical center

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingyen Hsiao, MD, phD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 11, 2023
• Study Start: June 24, 2019
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)