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Completed

NCT Number: NCT05808777

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone Interview

Other

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

Primary outcomes

  1. Barthel index

    Time frame: 12-month after ICH onset

    Barthel index score, range: 0-100, higher scores mean a better outcome

  2. Modified Rankin scale

    Time frame: 12-month after ICH onset

    Modified Rankin scale, range: 0-6, higher scores mean a worse outcome

Secondary outcomes

  1. Tube retention rate

    Time frame: 12-month after ICH onset

    Including Nasogastric (NG) tube, Foley catheter, tracheal tube

  2. Rehabilitation treatment course

    Time frame: 12-month after ICH onset

    Including inpatient rehabilitation and outpatient rehabilitation

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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