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

Intra Cerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808777
• Other study ID #: 201905045RINB
• Status: Completed
• Start date: June 24, 2019
• Est. completion date: June 23, 2022

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intra Cerebral Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel index	Barthel index score, range: 0-100, higher scores mean a better outcome	12-month after ICH onset
Primary	Modified Rankin scale	Modified Rankin scale, range: 0-6, higher scores mean a worse outcome	12-month after ICH onset
Secondary	Tube retention rate	Including Nasogastric (NG) tube, Foley catheter, tracheal tube	12-month after ICH onset
Secondary	Rehabilitation treatment course	Including inpatient rehabilitation and outpatient rehabilitation	12-month after ICH onset