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StrokeCOPINCT06548737

Clinical Outcomes Following Primary Intracerebral Hemorrhage

An observational study of Stroke and Intracerebral Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigators design an observational multi-center cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalized adult patients with primary intracerebral hemorrhage. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Stroke, Intracerebral Hemorrhage
How many people
25,000 participants
Where
1 siteChina
Study dates
27 Oct 2016to 31 Dec 2033
How long will I take part?
5 Years
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with acute primary intracerebral hemorrhage

Who may be able to join

  • We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures.

Who cannot join

  • We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS >2 before the current ICH episode (according to past medical records or description from guardians.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Feng Gao, Dr contact

+86-13588451471

2202012@zju.edu.cn

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310009

    Feng Gao, Dr, +86-13588451471, 2202012@zju.edu.cn

    Feng Gao, Dr

    Recruiting

Other trials in China

About this study

Official title: Clinical Outcomes Following Primary Intracerebral Hemorrhage：A Multicenter Cohort Study

The investigators design an observational multi-center cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalized adult patients with primary intracerebral hemorrhage.

Read the detailed description

This cohort was an analysis based on patients from six stroke centers: the 2nd Affiliated Hospital of Zhejiang University; the First People's Hospital of Pinghu, Jiaxing; the First People's Hospital of Taizhou; the People's Hospital of Haiyan, Jiaxing; Tiantai County People's Hospital, Taizhou; the 2nd People's Hospital of Quzhou (Please see more information of this cohort in supplement). All hospitals are located in Zhejiang Province. Patients' data were entered by local trained registrars using standardised protocols, and the overall process of case registration, monitoring of the data quality, and inquiry and correction of erroneous data was managed and supervised by a steering committee.

We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures. We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS >2 before the current ICH episode (according to past medical records or description from guardians.

This study was approved by human research ethic committees at all participating centers, and conducted in compliance with the principles set forward by the Declaration of Helsinki.

Keywords
Primary intracerebral hemorrhage, Stroke, Outcomes
Medical subject headings
Stroke, Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06548737
Study groupRoleWhat they receive
Patients with primary intracerebral hemorrhageWe included adult patients who (1) admitted for primary ICH; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures. We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS >2 before the current ICH episode (according to past medical records or description from guardians.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause death

    Patients die of any reasons

    Measured: 5 years after ICH

  2. ICH recurrence

    Patients had an another ICH after this ictus

    Measured: 5 years after ICH

  3. 3-month outcome

    3-month outcome is measured using modified Rankin Scale (mRS) score

    Measured: 3 months after ICH

Secondary outcomes (3)

  1. hematoma volume

    The volume of hematoma according to CT scan at the baseline when patients arrived at the emergency room

    Measured: up to 5 hours (A few hours after ICH)

  2. hematoma expansion

    Patients had another CT scan during 24-48 hours after the first CT, and hematoma volume growth exceeding 33% or absolute hematoma growth exceeding 6ml

    Measured: within 48 hours after ICH

  3. cerebral small vessel diseases (CSVDs)

    cerebral small vessel diseases evaluated by MRI, including cortical superficial siderosis (cSS), white matter hyperintensity (WMH), cerebral microbleed (CMB), etc.

    Measured: within 2 weeks after ICH

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start27 Oct 2016
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

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
Other
Enrolment
25,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06548737
Sponsor's protocol ID
ZJU
Acronym
COPI
Status last verified
Jun 2024
First submitted
8 Aug 2024
Last updated
12 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jin YJ, Yu GS, Tang LL, Li JW, Lin Q, Wu J, Song ZJ, An HN, Ye XH, Liu CJ, Gao F, Tong LS. Sex-specific hemoglobin thresholds and longitudinal trajectories in intracerebral hemorrhage outcomes: a multicenter cohort study. BMC Neurol. 2025 Jul 10;25(1):287. doi: 10.1186/s12883-025-04254-w.

    PubMed 40640707

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Intracerebral Hemorrhage, 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 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: looking for participants now, as of the sponsor's last update on 12 Aug 2024. 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?

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 Feng Gao, Dr (+86-13588451471, 2202012@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death (time frame: 5 years after ICH). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06548737, which also lists 1 linked publication.

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 12 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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