Surgical Evacuation Of Spontaneous Intracerebral Hematoma: Clinical Outcomes and Prognostic Factors
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mohamed A Ragheb, Demonstrator
- Phone Number: 01025921006
- Email: raghibov@gmail.com
Study Contact Backup
- Name: Ahmed S Mohamed, Professor
- Phone Number: 0100 3911767
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospitals
-
Contact:
- Magdy M Amin, Professor
- Phone Number: +20 109 0801900
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients with radiological findings of ICH.
- Age group 20-70 years.
Exclusion Criteria:
• Traumatic ICH or ruptured aneurysm or AVM or brain tumor.
- Postoperative cranial surgery ICH.
- Secondary hydrocephalus.
- Patients with other comorbidities e.g., Liver cell failure and renal cell failure.
- Patients with bleeding disorders.
- Patients who are regular on anticoagulant or antiplatelet therapy.
- Small sized ICH< 30 ml.
- GCS less than 6 preoperatively.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Surgical evacuation of Intracerebral hemorrhage
Surgical evacuation of Intracerebral hematoma
|
Surgical Evacuation of Intracerebral Hemorrhage
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morbidity after surgical evacuation of Intracerebral hematoma
Time Frame: 1 month
|
Complications within first month
|
1 month
|
|
Mortality after surgical evacuation of Intracerebral hematoma
Time Frame: 1 month
|
Death of patient within first month
|
1 month
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morbidity after surgical evacuation of Intracerebral hematoma
Time Frame: 3 months
|
Complications from end of 1st month to end of 3rd month
|
3 months
|
|
Mortality after surgical evacuation of Intracerebral hematoma
Time Frame: 3 months
|
Death of patient
|
3 months
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
- Wilkinson DA, Pandey AS, Thompson BG, Keep RF, Hua Y, Xi G. Injury mechanisms in acute intracerebral hemorrhage. Neuropharmacology. 2018 May 15;134(Pt B):240-248. doi: 10.1016/j.neuropharm.2017.09.033. Epub 2017 Sep 22.
- Wong JM, Ziewacz JE, Ho AL, Panchmatia JR, Kim AH, Bader AM, Thompson BG, Du R, Gawande AA. Patterns in neurosurgical adverse events: open cerebrovascular neurosurgery. Neurosurg Focus. 2012 Nov;33(5):E15. doi: 10.3171/2012.7.FOCUS12181.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Soh-Med--25-1-06MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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