Basal Ganglionic HemorrhageNCT06309940
Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage
An observational study of Basal Ganglionic Hemorrhage, run by Assiut University.
Trial summary
The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Basal Ganglionic Hemorrhage
- What is being tested?
- Prognostic factors of surgical evacuation of basal ganglionic haemorrhage
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Apr 2025
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Any adult patient of both sexes admitted to neurosurgery Department with non traumatic BG hemorrhage with total coverage of 1 year
Who may be able to join
- 1) patients aged between 15 and 60 years old ( elderly people>60 years were excluded since their strokes weren't routinely examined by CT scan in the emergency ward, however, in children<15 years old was due mostly to vascular malformations 2) CT scan showed basal ganglionic haemorrhage, with or without intraventricular extension within 24 hr post ictus 3) hematoma volume was 30 ml or above 4) Glasgow Coma Scale scores more than or equal 5 and stable vital signs
Who cannot join
- 1) intracerebral hemorrhage was caused by secondary factors e.g ( vascular malformations or head trauma) 2) GCS less than 5 or multiple intracranial hemorrhage 3) associated visceral disease e.g hepatic or renal or clotting disorder 4) patients with preexisting neurological deficit e.g previous intracerebral hemorrhage or infarction
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate
Read the detailed description
Spontaneous intracerebral hemorrhage is a common, mostly deadly stroke subtype and accounts for 10% to 15% of all strokes.
It's associated with a higher mortality rate (44% after 30 days) than either ischemic stroke or subarachnoid hemorrhage Up to 75% of the long term survivors are often suffering significant disability and only 12% to 39% of the survivors have favourable neurological functions recovered Rapid diagnosis and attentive management of patients is crucial because early deterioration is common Neurosurgical treatment for ICH has been discussed in recent multicentric studies, but no definitive answer of its utility has emerged.
Improved surgical techniques , neuroimaging, neuroanesthesia and perioperative monitoring and care have all led to improved outcomes from surgery
- Conditions
- Basal Ganglionic Hemorrhage
- Being tested
- Prognostic factors of surgical evacuation of basal ganglionic haemorrhage
- Medical subject headings
- Basal Ganglia Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic factors of surgical evacuation of basal ganglionic haemorrhageOther
Surgical evacuation of basal ganglionic haemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic factors of surgical evacuation of basal ganglionic haemorrhage
To investigate the effect of different factors on the outcome of the surgical evacuation of basal ganglionic haemorrhage
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Basal Ganglionic HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sameeh, Assiut University
- Investigators
- Farrag Mohamed, Doctor, Study chair, Assiut University neurosurgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309940
- Sponsor's protocol ID
- Basal ganglionic haemorrhage
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McCarron MO, Nicoll JA. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 Sep 6;345(10):769; author reply 770. doi: 10.1056/NEJM200109063451014. No abstract available.
PubMed 11547754Fernandes HM, Mendelow AD. Spontaneous intracerebral haemorrhage: a surgical dilemma. Br J Neurosurg. 1999 Aug;13(4):389-94. doi: 10.1080/02688699943501.
PubMed 10616566
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage
- ClinicalTrials.gov ID
- NCT06309940
- Acronym / sponsor ID
- Basal ganglionic haemorrhage
- Conditions
- Basal Ganglionic Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 13 Mar 2024 (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 aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate
Detailed description
Spontaneous intracerebral hemorrhage is a common, mostly deadly stroke subtype and accounts for 10% to 15% of all strokes.
It's associated with a higher mortality rate (44% after 30 days) than either ischemic stroke or subarachnoid hemorrhage Up to 75% of the long term survivors are often suffering significant disability and only 12% to 39% of the survivors have favourable neurological functions recovered Rapid diagnosis and attentive management of patients is crucial because early deterioration is common Neurosurgical treatment for ICH has been discussed in recent multicentric studies, but no definitive answer of its utility has emerged.
Improved surgical techniques , neuroimaging, neuroanesthesia and perioperative monitoring and care have all led to improved outcomes from surgery
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Any adult patient of both sexes admitted to neurosurgery Department with non traumatic BG hemorrhage with total coverage of 1 year
Key inclusion criteria (1 listed)
- 1) patients aged between 15 and 60 years old ( elderly people>60 years were excluded since their strokes weren't routinely examined by CT scan in the emergency ward, however, in children<15 years old was due mostly to vascular malformations 2) CT scan showed basal ganglionic haemorrhage, with or without intraventricular extension within 24 hr post ictus 3) hematoma volume was 30 ml or above 4) Glasgow Coma Scale scores more than or equal 5 and stable vital signs
Key exclusion criteria (1 listed)
- 1) intracerebral hemorrhage was caused by secondary factors e.g ( vascular malformations or head trauma) 2) GCS less than 5 or multiple intracranial hemorrhage 3) associated visceral disease e.g hepatic or renal or clotting disorder 4) patients with preexisting neurological deficit e.g previous intracerebral hemorrhage or infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognostic factors of surgical evacuation of basal ganglionic haemorrhageSurgical evacuation of basal ganglionic haemorrhage | Other | – |
Primary outcome
Prognostic factors of surgical evacuation of basal ganglionic haemorrhage
Time frame: Baseline
To investigate the effect of different factors on the outcome of the surgical evacuation of basal ganglionic haemorrhage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 11547754McCarron MO, Nicoll JA. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 Sep 6;345(10):769; author reply 770. doi: 10.1056/NEJM200109063451014. No abstract available.
- Background: PubMed 10616566Fernandes HM, Mendelow AD. Spontaneous intracerebral haemorrhage: a surgical dilemma. Br J Neurosurg. 1999 Aug;13(4):389-94. doi: 10.1080/02688699943501.
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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.
Farrag Mohamed, Doctor study chair
Assiut University neurosurgery Department
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Ganglionic Hemorrhage, run by Assiut University.
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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Sameeh, Master (01022690894, ahmedsameeh18497@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic factors of surgical evacuation of basal ganglionic haemorrhage (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309940, which also lists 2 linked publications.
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 Mar 2024.