NCT05502874

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 16, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

July 31, 2022

Last Update Submit

August 14, 2022

Conditions

Intracerebral HemorrhageNeurologic DeficitsHemorrhagic StrokeHemorrhage

Keywords

Intracerebral HemorrhageNeurological DeteriorationNeuroimagingPrognosis

Outcome Measures

Primary Outcomes (1)

  • 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

    48 hours after admission

Secondary Outcomes (6)

  • Late neurological deterioration (LND)

    7 days

  • Functional outcome

    90 days, 1 year, 2 years after admission

  • Hematoma expansion

    24 hours after admission

  • The quality of life

    90 days, 1 year, 2 years after admission

  • Depression status

    90 days, 1 year, 2 years after admission

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.

You may qualify if:

  • Confirmed diagnosis of primary intracerebral hemorrhage

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Cerebral HemorrhageNeurologic ManifestationsHemorrhagic StrokeHemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsStroke

Central Study Contacts

Feng Gao, MD,PhD

CONTACT

135884514712202012@zju.edu.cn

Lusha Tong, MD,PhD

CONTACT

158681712182310040@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 16, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2024

Study Completion

October 1, 2025

Last Updated

August 16, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)