Intracerebral HemorrhageNCT04783922
An Update on Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage and Stroke, run by Shifa Clinical Research Center at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Stroke, Hematoma
- How many people
- 1,000 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2021to Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not willing to participate Secondary ICH to hemorrhagic infarction or tumor bleeding etc. Traumatic ICH
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa Tameer e Millat University
Islamabad, 46000
Muhammad Junaid Akram, PhD*, drjunaidmalik2@gmail.com
About this study
Official title: An Update on Intracerebral Hemorrhage - A Cohort Study
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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage, Stroke, Hematoma
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematoma volume growth at 24 hours
To assess early hematoma volume growth at 24 hours
Measured: 24 hours
Secondary outcomes (9)
Functional outcome at 3 months assessed by modified Rankin Scale
Assess functional outcome at 3 months by using mRS
Measured: 3 months
Early neurological deterioration assessed by NIHSS score at 24 hours
To assess early neurological deterioration by using NIHSS score at 24 hours
Measured: 24 hours
Early neurological deterioration assessed by NIHSS score at 48 hours
To assess early neurological deterioration by using NIHSS score at 48 hours
Measured: 48 hours
Early neurological deterioration assessed by NIHSS score at 72 hours
To assess early neurological deterioration by using NIHSS score at 72 hours
Measured: 72 hours
Perihematomal edema volume measurement at 24 hours
To measure the perihematomal edema volume growth at 24 hours
Measured: 24 hours
Perihematomal edema volume measurement at 48 hours
To measure the perihematomal edema volume growth at 48 hours
Measured: 48 hours
Perihematomal edema volume measurement at 72 hours
To measure the perihematomal edema volume growth at 72 hours
Measured: 72 hours
Intraventricular hemorrhage growth
To assess the presence of IVH at 24 hours
Measured: 24 hours
Major thrombotic events
To assess the thrombotic events 2 weeks after admission
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start17 Mar 2021
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Clinical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shifa International Hospital, Chongqing Medical University
- Responsible party
- Principal investigator, Dr. Muhammad Junaid Akram, Shifa Clinical Research Center
- Investigators
- Muhammad Junaid Akram, DPT, MS-NMPT, Principal investigator, Chongqing Medical University, Chongqing / Shifa Tameer e Millat University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783922
- Sponsor's protocol ID
- IRB-Approval- Submitted
- Status last verified
- Apr 2021
- First submitted
- 2 Mar 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Update on Intracerebral Hemorrhage - A Cohort Study
- ClinicalTrials.gov ID
- NCT04783922
- Acronym / sponsor ID
- IRB-Approval- Submitted
- Conditions
- Intracerebral Hemorrhage, Stroke, Hematoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shifa Clinical Research CenterUniversity, hospital or other
- Collaborators
- Shifa International Hospital, Chongqing Medical University
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to participate Secondary ICH to hemorrhagic infarction or tumor bleeding etc. Traumatic ICH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hematoma volume growth at 24 hours
Time frame: 24 hours
To assess early hematoma volume growth at 24 hours
9 secondary outcomes
Functional outcome at 3 months assessed by modified Rankin Scale
Time frame: 3 months
Early neurological deterioration assessed by NIHSS score at 24 hours
Time frame: 24 hours
Early neurological deterioration assessed by NIHSS score at 48 hours
Time frame: 48 hours
Early neurological deterioration assessed by NIHSS score at 72 hours
Time frame: 72 hours
Perihematomal edema volume measurement at 24 hours
Time frame: 24 hours
Perihematomal edema volume measurement at 48 hours
Time frame: 48 hours
Perihematomal edema volume measurement at 72 hours
Time frame: 72 hours
Intraventricular hemorrhage growth
Time frame: 24 hours
Major thrombotic events
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: Undecided. Undecided yet
Related trials for Intracerebral Hemorrhage
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Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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PREcision MApping and NEuromodulation After Spontaneous Intracerebral Hemorrhage: The PREMANE Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Junaid Akram, DPT, MS-NMPT principal investigator
Chongqing Medical University, Chongqing / Shifa Tameer e Millat University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage and Stroke, run by Shifa Clinical Research Center at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Junaid Akram, DPT, MS-NMPT (0092-335-1402214, drjunaidmalik2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematoma volume growth at 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.