An Update on Intracerebral Hemorrhage

• Conditions: Stroke; Hematoma; Intracerebral Hemorrhage

• Registration Number: NCT04783922
• Lead Sponsor: Shifa Clinical Research Center

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 Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-03-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-04-13
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hematoma volume growth at 24 hours	24 hours	To assess early hematoma volume growth at 24 hours

Secondary Outcome Measures

Name	Time	Method
Perihematomal edema volume measurement at 24 hours	24 hours	To measure the perihematomal edema volume growth at 24 hours
Perihematomal edema volume measurement at 48 hours	48 hours	To measure the perihematomal edema volume growth at 48 hours
Perihematomal edema volume measurement at 72 hours	72 hours	To measure the perihematomal edema volume growth at 72 hours
Major thrombotic events	2 weeks	To assess the thrombotic events 2 weeks after admission
Functional outcome at 3 months assessed by modified Rankin Scale	3 months	Assess functional outcome at 3 months by using mRS
Early neurological deterioration assessed by NIHSS score at 24 hours	24 hours	To assess early neurological deterioration by using NIHSS score at 24 hours
Early neurological deterioration assessed by NIHSS score at 48 hours	48 hours	To assess early neurological deterioration by using NIHSS score at 48 hours
Intraventricular hemorrhage growth	24 hours	To assess the presence of IVH at 24 hours
Early neurological deterioration assessed by NIHSS score at 72 hours	72 hours	To assess early neurological deterioration by using NIHSS score at 72 hours

Trial Locations

Locations (1)

Shifa Tameer e Millat University; 🇵🇰 Islamabad, Pakistan