An Update on Intracerebral Hemorrhage

NCT04783922 | Unknown

• 1 other identifier: IRB-Approval- Submitted
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage; Stroke; Hematoma

Outcome Measures

Primary Outcomes (1)

• hematoma volume growth at 24 hours

  To assess early hematoma volume growth at 24 hours

  24 hours

Secondary Outcomes (9)

• 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

• Early neurological deterioration assessed by NIHSS score at 72 hours

  72 hours

• Perihematomal edema volume measurement at 24 hours

  24 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Not willing to participate Secondary ICH to hemorrhagic infarction or tumor bleeding etc. Traumatic ICH

Sponsors & Collaborators

• Shifa Clinical Research Center: lead
• Shifa International Hospital: collaborator
• Chongqing Medical University: collaborator

Study Sites (1)

Shifa Tameer e Millat University

Islamabad, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Hematoma

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Junaid Akram, DPT, MS-NMPT

  Chongqing Medical University, Chongqing / Shifa Tameer e Millat University, Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Junaid Akram, DPT, MS-NMPT

CONTACT

0092-335-1402214; drjunaidmalik2@gmail.com

Muhammad Junaid Akram

CONTACT

0092-335-1402214; drjunaidmalik2@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Muhammad Junaid Akram

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: March 17, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

PA (1)