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Clinical Trials/NCT04783922
NCT04783922
Unknown
Not Applicable

An Update on Intracerebral Hemorrhage - A Cohort Study

Shifa Clinical Research Center1 site in 1 country1,000 target enrollmentMarch 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracerebral Hemorrhage
Sponsor
Shifa Clinical Research Center
Enrollment
1000
Locations
1
Primary Endpoint
hematoma volume growth at 24 hours
Last Updated
5 years ago

Overview

Brief Summary

The intracerebral hemorrhage study is a multicenter , combination of prospective and retrospective observational cohort study led by Dr. Muhammad Junaid Akram, PhD scholar at Chongqing Medical University. Prof Dr. Qi Li will be the senior consultant for the study. The study will be focusing on natural history, epidemiological , radiological, rehabilitative and clinical aspects as well as the effect of various treatments on the hemorrhagic patients.

The study related data of the patients diagnosed with intracerebral hemorrhage will be collected in prospective and retrospective ways. The prognostic data for the patients will be assembled and collected via using different outcome measures at different points of time.

Detailed Description

The study will be used to address the several key issues related to intracerebral hemorrhage. The demographics, scores based upon disease severity , mRS, GCS, NIHSS scores will be recorded at baseline and in the prospective and retrospective ways. The data obtained from the registered patients will be used for future use , critical review by expert neurologists, neurorehabilitative experts for further use and review.

Registry
clinicaltrials.gov
Start Date
March 17, 2021
End Date
February 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shifa Clinical Research Center
Responsible Party
Principal Investigator
Principal Investigator

Dr. Muhammad Junaid Akram

Dr. Muhammad Junaid Akram

Shifa Clinical Research Center

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years Patients willing to participate via signing a consent form' Patients diagnosed with CT-Confirmed spontaneous intracerebral hemorrhage (ICH) Patients willing to participate in the follow up assessment

Exclusion Criteria

  • Not willing to participate Secondary ICH to hemorrhagic infarction or tumor bleeding etc. Traumatic ICH

Outcomes

Primary Outcomes

hematoma volume growth at 24 hours

Time Frame: 24 hours

To assess early hematoma volume growth at 24 hours

Secondary Outcomes

  • Perihematomal edema volume measurement at 24 hours(24 hours)
  • Perihematomal edema volume measurement at 48 hours(48 hours)
  • Perihematomal edema volume measurement at 72 hours(72 hours)
  • Major thrombotic events(2 weeks)
  • Functional outcome at 3 months assessed by modified Rankin Scale(3 months)
  • Early neurological deterioration assessed by NIHSS score at 24 hours(24 hours)
  • Early neurological deterioration assessed by NIHSS score at 48 hours(48 hours)
  • Intraventricular hemorrhage growth(24 hours)
  • Early neurological deterioration assessed by NIHSS score at 72 hours(72 hours)

Study Sites (1)

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