Intra Cerebral HemorrhageNCT05808777
Validation of the ICH Score for the Prediction of 12-month Functional Outcome in Patients With Primary Intracerebral Hemorrhage
An observational study of Intra Cerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intra Cerebral Hemorrhage
- What is being tested?
- Phone interview
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2019to 23 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A tertiary medical center
Who may be able to join
- 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
Who cannot join
- ICH related to aneurysm, arteriovenous malformation, or trauma
- Died before discharge
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Phone interview
- Keywords
- Intracerebral hemorrhage, Functional outcome, Prognosis, Survivors, Rehabilitation
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone interviewOther
A interview follow-up with a physician by phone was performed at 12 months after the onset of ICH.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index
Barthel index score, range: 0-100, higher scores mean a better outcome
Measured: 12-month after ICH onset
Modified Rankin scale
Modified Rankin scale, range: 0-6, higher scores mean a worse outcome
Measured: 12-month after ICH onset
Secondary outcomes (2)
Tube retention rate
Including Nasogastric (NG) tube, Foley catheter, tracheal tube
Measured: 12-month after ICH onset
Rehabilitation treatment course
Including inpatient rehabilitation and outpatient rehabilitation
Measured: 12-month after ICH onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start24 Jun 2019
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingyen Hsiao, MD, phD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808777
- Sponsor's protocol ID
- 201905045RINB
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the ICH Score for the Prediction of 12-month Functional Outcome in Patients With Primary Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05808777
- Acronym / sponsor ID
- 201905045RINB
- Conditions
- Intra Cerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, Functional outcome, Prognosis, Survivors, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICH | – | Other: Phone interviewPatients 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A tertiary medical center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- ICH related to aneurysm, arteriovenous malformation, or trauma
- Died before discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone interviewA interview follow-up with a physician by phone was performed at 12 months after the onset of ICH. | Other | ICH |
Primary outcome
Barthel index
Time frame: 12-month after ICH onset
Barthel index score, range: 0-100, higher scores mean a better outcome
Modified Rankin scale
Time frame: 12-month after ICH onset
Modified Rankin scale, range: 0-6, higher scores mean a worse outcome
2 secondary outcomes
Tube retention rate
Time frame: 12-month after ICH onset
Rehabilitation treatment course
Time frame: 12-month after ICH onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingyen Hsiao, MD, phD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra Cerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel index (time frame: 12-month after ICH onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.