Intracerebral HemorrhageRESEARCHNCT06629532
The REgistry Study on Multimodality trEAtment foR Cerebral Hemorrhage
An observational study of Intracerebral Hemorrhage, run by Tao Liu.
Trial summary
The REgistry Study on multimodality trEAtment foR Cerebral Hemorrhage (RESEARCH) aims to address these challenges by establishing a comprehensive national registry. This initiative will collect detailed, longitudinal data on the clinical characteristics, treatment modalities, and outcomes of patients with ICH across… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- medical management, surgical interventions, and rehabilitative strategies
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 15 Oct 2049
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cerebral hemorrhage from various causes
Who may be able to join
- Cerebral hemorrhage
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The REgistry Study on multimodality trEAtment foR Cerebral Hemorrhage (RESEARCH) aims to address these challenges by establishing a comprehensive national registry. This initiative will collect detailed, longitudinal data on the clinical characteristics, treatment modalities, and outcomes of patients with ICH across various regions. By leveraging a wide array of treatment data - including medical management, surgical interventions, and rehabilitative strategies - the RESEARCH registry intends to provide a granular view of current treatment landscapes and their direct impact on patient recovery and quality of life.
Read the detailed description
Cerebral hemorrhage, also known as intracerebral hemorrhage (ICH), is a severe neurological condition characterized by abrupt bleeding within the brain tissues, leading to high rates of mortality and morbidity worldwide. In China, where the burden of cerebrovascular diseases is substantial due to the aging population and prevalence of risk factors such as hypertension and diabetes, the impact of ICH is particularly pronounced. Despite advancements in medical science, the prognosis for patients suffering from ICH remains poor, with a high proportion of survivors experiencing significant disability.
Current treatment protocols for ICH involve a range of strategies, from conservative management to surgical interventions. However, the heterogeneity in clinical practices and patient responses highlights a significant gap in standardized treatment efficacy.
This registry study is not only pivotal for enhancing the understanding of effective treatment combinations but also crucial for identifying potential disparities in the application of treatment modalities across different healthcare settings. Through the analytical power of this large-scale, multicentric data, RESEARCH will contribute significantly to optimizing treatment paradigms and ultimately, shaping policy changes that aim to reduce the mortality and enhance the recovery rates of patients suffering from cerebral hemorrhage.
There is an urgent need to evaluate these multimodal treatment approaches on a broader scale to understand their real-world effectiveness and develop guidelines that can be systematically applied to improve patient outcomes.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- medical management, surgical interventions, and rehabilitative strategies
- Keywords
- intracerebral hemorrhage, Outcome, Management, Surgical interventions, Real-world, Disparities, Multicentric data
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical management, surgical interventions, and rehabilitative strategiesOther
By leveraging a wide array of treatment data - including medical management, surgical interventions, and rehabilitative strategies - the RESEARCH registry intends to provide a granular view of current treatment landscapes and their direct impact on patient recovery and quality of life.
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Score (mRS)
0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death
Measured: at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Oct 2044 (estimated)
- Study completion15 Oct 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- 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
- 100,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tao Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
- Responsible party
- Sponsor-investigator, Tao Liu, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629532
- Sponsor's protocol ID
- Thegeorgeinstitute
- Other IDs
- 82071390, 82271394, 8247050928
- Acronym
- RESEARCH
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REgistry Study on Multimodality trEAtment foR Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06629532
- Acronym / sponsor ID
- RESEARCH / Thegeorgeinstitute
- Conditions
- Intracerebral Hemorrhage
- Keywords
- intracerebral hemorrhage, Outcome, Management, Surgical interventions, Real-world, Disparities, Multicentric data
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Tao LiuUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Oct 2044 (estimated)
- Study completion
- 15 Oct 2049 (estimated)
- First posted
- 8 Oct 2024 (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 REgistry Study on multimodality trEAtment foR Cerebral Hemorrhage (RESEARCH) aims to address these challenges by establishing a comprehensive national registry. This initiative will collect detailed, longitudinal data on the clinical characteristics, treatment modalities, and outcomes of patients with ICH across various regions. By leveraging a wide array of treatment data - including medical management, surgical interventions, and rehabilitative strategies - the RESEARCH registry intends to provide a granular view of current treatment landscapes and their direct impact on patient recovery and quality of life.
Detailed description
Cerebral hemorrhage, also known as intracerebral hemorrhage (ICH), is a severe neurological condition characterized by abrupt bleeding within the brain tissues, leading to high rates of mortality and morbidity worldwide. In China, where the burden of cerebrovascular diseases is substantial due to the aging population and prevalence of risk factors such as hypertension and diabetes, the impact of ICH is particularly pronounced. Despite advancements in medical science, the prognosis for patients suffering from ICH remains poor, with a high proportion of survivors experiencing significant disability.
Current treatment protocols for ICH involve a range of strategies, from conservative management to surgical interventions. However, the heterogeneity in clinical practices and patient responses highlights a significant gap in standardized treatment efficacy.
This registry study is not only pivotal for enhancing the understanding of effective treatment combinations but also crucial for identifying potential disparities in the application of treatment modalities across different healthcare settings. Through the analytical power of this large-scale, multicentric data, RESEARCH will contribute significantly to optimizing treatment paradigms and ultimately, shaping policy changes that aim to reduce the mortality and enhance the recovery rates of patients suffering from cerebral hemorrhage.
There is an urgent need to evaluate these multimodal treatment approaches on a broader scale to understand their real-world effectiveness and develop guidelines that can be systematically applied to improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cerebral hemorrhage from various causes
Key inclusion criteria (1 listed)
- Cerebral hemorrhage
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| medical management, surgical interventions, and rehabilitative strategiesBy leveraging a wide array of treatment data - including medical management, surgical interventions, and rehabilitative strategies - the RESEARCH registry intends to provide a granular view of current treatment landscapes and their direct impact on patient recovery and quality of life. | Other | – |
Primary outcome
modified Rankin Score (mRS)
Time frame: at least 6 months
0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by Tao Liu.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Liu, MD (61-466068193 ext. 86-18302204804, TLiu1@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Score (mRS) (time frame: at least 6 months). 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 8 Oct 2024.