Clinical trial NCT04783922: An Update on Intracerebral Hemorrhage
Official title: An Update on Intracerebral Hemorrhage - A Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracerebral Hemorrhage
Stroke
Hematoma
Lead sponsor: Shifa Clinical Research Center
Sponsor class: OTHER
Collaborators: name: Shifa International Hospital
name: Chongqing Medical University
First posted: 2021-03-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: hematoma volume growth at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Functional outcome at 3 months assessed by modified Rankin Scale
timeFrame: 3 months
measure: Early neurological deterioration assessed by NIHSS score at 24 hours
timeFrame: 24 hours
measure: Early neurological deterioration assessed by NIHSS score at 48 hours
timeFrame: 48 hours
measure: Early neurological deterioration assessed by NIHSS score at 72 hours
timeFrame: 72 hours
measure: Perihematomal edema volume measurement at 24 hours
timeFrame: 24 hours
measure: Perihematomal edema volume measurement at 48 hours
timeFrame: 48 hours
measure: Perihematomal edema volume measurement at 72 hours
timeFrame: 72 hours
measure: Intraventricular hemorrhage growth
timeFrame: 24 hours
measure: Major thrombotic events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shifa Tameer e Millat University
Study officials:
affiliation: Chongqing Medical University, Chongqing / Shifa Tameer e Millat University, Islamabad
name: Muhammad Junaid Akram, DPT, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References: