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Clinical Trials/NCT04783922
NCT04783922UnknownNot Applicable

An Update on Intracerebral Hemorrhage - A Cohort Study

Shifa Clinical Research Center1 site in 1 country1,000 target enrollmentStarted: March 17, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
hematoma volume growth at 24 hours

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Shifa Clinical Research Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Muhammad Junaid Akram

Dr. Muhammad Junaid Akram

Shifa Clinical Research Center

Study Sites (1)

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