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NCT Number: NCT06548737

Clinical Outcomes Following Primary Intracerebral Hemorrhage

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Feng Gao, Dr

CONTACT

[email protected]

+86-13588451471

Feng Gao, Dr

PRINCIPAL_INVESTIGATOR

Guoshen Yu, MD

SUB_INVESTIGATOR

Hongna An, MD

SUB_INVESTIGATOR

Jian Wu, MD

SUB_INVESTIGATOR

Jiawen Li, Dr

SUB_INVESTIGATOR

Kaicheng Yang, MD

SUB_INVESTIGATOR

Lili Tang, MD

SUB_INVESTIGATOR

Lusha Tong, Dr

SUB_INVESTIGATOR

Qing Lin, Dr

SUB_INVESTIGATOR

Xianghua Ye, Dr

SUB_INVESTIGATOR

Yujia Jin, Dr

SUB_INVESTIGATOR

Zaijun Song, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. All-cause death

    Time frame: 5 years after ICH

    Patients die of any reasons

  2. ICH recurrence

    Time frame: 5 years after ICH

    Patients had an another ICH after this ictus

  3. 3-month outcome

    Time frame: 3 months after ICH

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

Secondary outcomes

  1. hematoma volume

    Time frame: up to 5 hours (A few hours after ICH)

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

  2. hematoma expansion

    Time frame: within 48 hours after ICH

    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

  3. cerebral small vessel diseases (CSVDs)

    Time frame: within 2 weeks after ICH

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

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Gao, Dr

CONTACT

[email protected]

+86-13588451471

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Haiyan People's Hospital
  • Taizhou First People's Hospital
  • The 2nd People's Hospital of Quzhou
  • The First People's Hospital of Pinghu

Registry information

Official study title

Clinical Outcomes Following Primary Intracerebral Hemorrhage:A Multicenter Cohort Study

Acronym: COPI

Important dates

Study start
2016
Primary completion
2030
Study completion
2033
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

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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