Intracerebral HemorrhageCATCHNCT05502874
Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage and Neurologic Deficits, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This multicenter observational study will explore the risk factors of early neurological deterioration(END) in patients with primary and to investigate the association between END and outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Neurologic Deficits, Hemorrhagic Stroke
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Oct 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.
Who may be able to join
- Confirmed diagnosis of primary intracerebral hemorrhage
Who cannot join
- Patients with secondary
- Undergo surgical evacuation of hematoma；
- Presenting contraindications or refusal to MRI
- Is pregnant
- Patients refuse to be followed up for any reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, 310000
Feng Gao, MD,PhD, 13588451471, 2202012@zju.edu.cn
About this study
This multicenter observational study will explore the risk factors of early neurological deterioration(END) in patients with primary and to investigate the association between END and outcome.
Read the detailed description
Neurological deterioration affects approximately one-third of patients with primary intracerebral hemorrhage (ICH) and increases the risk of death and dependency. However, the risk factors of early neurological deterioration (END), such as biochemical parameters, neuroimaging, and systemic complications, are not well documented in primary ICH, and the effective predictors of END is unknown.
This multicenter observational study aims to seek out the risk factors of END in patients with primary ICH and to investigate the association between END and outcome.
- Keywords
- Intracerebral Hemorrhage, Neurological Deterioration, Neuroimaging, Prognosis
- Medical subject headings
- Cerebral Hemorrhage, Neurologic Manifestations, Hemorrhagic Stroke, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Early neurological deterioration (END)
END is defined as an increase in the total NIHSS score of ≥ 4 points within the first 48 h after admission
Measured: 48 hours after admission
Secondary outcomes (6)
Late neurological deterioration (LND)
LND is defined as an increase in the total NIHSS score of ≥ 4 points between 48h and 7 days after admission
Measured: 7 days
Functional outcome
Functional outcome will be assessed with modified ranking scale(mRS).Poor outcome is defined as mRS 4-6 at follow-up
Measured: 90 days, 1 year, 2 years after admission
Hematoma expansion
Hematoma volume expansion of at least 6 mL or 33% on a CT scan obtained 24 hours after admission compared with the entry scan.
Measured: 24 hours after admission
The quality of life
The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.
Measured: 90 days, 1 year, 2 years after admission
Depression status
Patient Health Questionnaire (PHQ)-9 scale will be evaluated, and higher scores means a worse status.
Measured: 90 days, 1 year, 2 years after admission
Cognitive function
Telephone Interview for Cognitive Status-Modified(TICS-m) scale will be evaluated via telephone interview.
Measured: 90 days, 1 year, 2 years after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Oct 2025 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 1,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502874
- Sponsor's protocol ID
- 08268522
- Acronym
- CATCH
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05502874
- Acronym / sponsor ID
- CATCH / 08268522
- Keywords
- Intracerebral Hemorrhage, Neurological Deterioration, Neuroimaging, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 16 Aug 2022 (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.
This multicenter observational study will explore the risk factors of early neurological deterioration(END) in patients with primary and to investigate the association between END and outcome.
Detailed description
Neurological deterioration affects approximately one-third of patients with primary intracerebral hemorrhage (ICH) and increases the risk of death and dependency. However, the risk factors of early neurological deterioration (END), such as biochemical parameters, neuroimaging, and systemic complications, are not well documented in primary ICH, and the effective predictors of END is unknown.
This multicenter observational study aims to seek out the risk factors of END in patients with primary ICH and to investigate the association between END and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.
Key inclusion criteria (1 listed)
- Confirmed diagnosis of primary intracerebral hemorrhage
Key exclusion criteria (5 listed)
- Patients with secondary
- Undergo surgical evacuation of hematoma；
- Presenting contraindications or refusal to MRI
- Is pregnant
- Patients refuse to be followed up for any reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early neurological deterioration (END)
Time frame: 48 hours after admission
END is defined as an increase in the total NIHSS score of ≥ 4 points within the first 48 h after admission
6 secondary outcomes
Late neurological deterioration (LND)
Time frame: 7 days
Functional outcome
Time frame: 90 days, 1 year, 2 years after admission
Hematoma expansion
Time frame: 24 hours after admission
The quality of life
Time frame: 90 days, 1 year, 2 years after admission
Depression status
Time frame: 90 days, 1 year, 2 years after admission
Cognitive function
Time frame: 90 days, 1 year, 2 years after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Intracerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
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.
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 Intracerebral Hemorrhage and Neurologic Deficits, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Gao, MD,PhD (13588451471, 2202012@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early neurological deterioration (END) (time frame: 48 hours after admission). 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 16 Aug 2022.