An Update on Intracerebral Hemorrhage

Stroke Clinical Trial

Official title:

An Update on Intracerebral Hemorrhage - A Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783922
• Other study ID #: IRB-Approval- Submitted
• Status: Recruiting
• Start date: March 17, 2021
• Est. completion date: February 2022

Study information

• Verified date: April 2021
• Source: Shifa Clinical Research Center
• Contact: Muhammad Junaid Akram, DPT, MS-NMPT
• Phone: 0092-335-1402214
• Email: drjunaidmalik2[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hematoma
• Hemorrhage
• Intracerebral Hemorrhage
• Stroke

Locations

Country	Name	City	State
Pakistan	Shifa Tameer e Millat University	Islamabad

Sponsors (3)

Lead Sponsor	Collaborator
Shifa Clinical Research Center	Chongqing Medical University, Shifa International Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

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