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An Update on Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT04783922
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Shifa International Hospital
Chongqing Medical University
Information provided by (Responsible Party):
Dr. Muhammad Junaid Akram, Shifa Clinical Research Center

Study Description
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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.


Condition or disease
Intracerebral Hemorrhage Stroke Hematoma

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
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Update on Intracerebral Hemorrhage - A Cohort Study
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort
Benign Hematoma
Patients (having novel image markers or clinical features) suggestive of a benign hematoma relatively , that is having relatively good prognostic outcome and less likely to expand.
Malignant Hematoma
Patients (having novel image markers or clinical features) suggestive of a malignant hematoma relatively, that is more likely to expand and have poor prognostic outcome.


Outcome Measures
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Primary Outcome Measures :
  1. hematoma volume growth at 24 hours [ Time Frame: 24 hours ]
    To assess early hematoma volume growth at 24 hours


Secondary Outcome Measures :
  1. Functional outcome at 3 months assessed by modified Rankin Scale [ Time Frame: 3 months ]
    Assess functional outcome at 3 months by using mRS

  2. Early neurological deterioration assessed by NIHSS score at 24 hours [ Time Frame: 24 hours ]
    To assess early neurological deterioration by using NIHSS score at 24 hours

  3. Early neurological deterioration assessed by NIHSS score at 48 hours [ Time Frame: 48 hours ]
    To assess early neurological deterioration by using NIHSS score at 48 hours

  4. Early neurological deterioration assessed by NIHSS score at 72 hours [ Time Frame: 72 hours ]
    To assess early neurological deterioration by using NIHSS score at 72 hours

  5. Perihematomal edema volume measurement at 24 hours [ Time Frame: 24 hours ]
    To measure the perihematomal edema volume growth at 24 hours

  6. Perihematomal edema volume measurement at 48 hours [ Time Frame: 48 hours ]
    To measure the perihematomal edema volume growth at 48 hours

  7. Perihematomal edema volume measurement at 72 hours [ Time Frame: 72 hours ]
    To measure the perihematomal edema volume growth at 72 hours

  8. Intraventricular hemorrhage growth [ Time Frame: 24 hours ]
    To assess the presence of IVH at 24 hours

  9. Major thrombotic events [ Time Frame: 2 weeks ]
    To assess the thrombotic events 2 weeks after admission


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be comprising of the participants willing to participate in the study with an age greater than 18 years from Pakistan.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783922


Contacts
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Contact: Muhammad Junaid Akram, DPT, MS-NMPT 0092-335-1402214 drjunaidmalik2@gmail.com
Contact: Muhammad Junaid Akram 0092-335-1402214 drjunaidmalik2@gmail.com

Locations
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Pakistan
Shifa Tameer e Millat University Recruiting
Islamabad, Pakistan, 46000
Contact: Muhammad Junaid Akram, PhD*       drjunaidmalik2@gmail.com   
Sponsors and Collaborators
Shifa Clinical Research Center
Shifa International Hospital
Chongqing Medical University
Investigators
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Principal Investigator: Muhammad Junaid Akram, DPT, MS-NMPT Chongqing Medical University, Chongqing / Shifa Tameer e Millat University, Islamabad
More Information
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Responsible Party: Dr. Muhammad Junaid Akram, Shifa Clinical Research Center
ClinicalTrials.gov Identifier: NCT04783922    
Other Study ID Numbers: IRB-Approval- Submitted
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Hematoma
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases