HydrocephalusNCT06703164
Late Post Traumatic Ventriculomegally Does it Requires CSF Diversion ?
An observational study of Hydrocephalus and Ventriculomegally, run by Assiut University.
Trial summary
Aim of the study is : 1. prevelance of ventriculomegally in post traumatic patients after head trauma 2. To determine the incidence of surgically treated ventriculomegally within 6 months from head injury in a series of consecutive adult patients undergoing acute head CT following injury. 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus, Ventriculomegally
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ventricular enlargement is a common finding after severe head injury.[1] This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss.[2] late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury The choice of the term ventriculomegally in the title reflects the difficulty in differentiating a ventricular enlargement (secondary to post-traumatic brain damage with atrophy) from an active hydrocephalic process. A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery [11,12]. Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation [13,14].
Who may be able to join
- All post traumatic patients showing ventriculomegally in ct brain f/u (2week to 6months) after trauma.
Who cannot join
- 1.Any patient whose initial ct brain after head trauma showing ventriculomegally 2.any patient develops ventriculomegally within first 2 weeks of trauma or beyond 6 months of trauma.
- 3.any patient has hx of previous csf diversion .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Aim of the study is :
- prevelance of ventriculomegally in post traumatic patients after head trauma
- To determine the incidence of surgically treated ventriculomegally within 6 months from head injury in a series of consecutive adult patients undergoing acute head CT following injury.
- importance of csf diversion in post traumatic ventriculomegally
Read the detailed description
Ventricular enlargement is a common finding after severe head injury.This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss.[ late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury .
Its incidence deeply varies among series (0.7-50%), and this is mainly due to very different diagnostic criteria Therefore, given the very high number of patients with traumatic brain injury (TBIs), patients presenting with late post-traumatic ventriculomegally are not infrequent.
The choice of the term ventriculomegally in the title reflects the difficulty in differentiating a ventricular enlargement (secondary to post-traumatic brain damage with atrophy) from an active hydrocephalic process.
Those patients with subarachnoid hemorrhage (SAH) had a threefold risk of developing ventriculomegally compared to patients with no SAH during the 2-year follow-up period. Also, decompressive craniectomy and the presence of subdural hygroma after craniectomy seem to increase the risk for ventriculomegally.In craniectomy, the proximity of the craniotomy to the skull midline might increase the risk as well. Other possible risk factors for post traumatic ventriculomegaly include: increased age, cerebrospinal fuid infection, and intraventricular hemorrhage . Inflammation-mediated adhesions related to intracranial hemorrhages can explain the predisposition to post traumatic ventriculomegally.
In fact, practically all patients with post-traumatic ventricular enlargement present with symptoms of post-taumatic Lesions and almost never present with the Hakim-adams trriad. Some of them present nonspecific symptoms, especially arrested clinical improvement during rehabilitation programs, impaired consciousness or a worsening neurologic status .
A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery .
Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation
- Conditions
- Hydrocephalus, Ventriculomegally
- Keywords
- Post Traumatic Hcp
- Medical subject headings
- Hydrocephalus
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 |
|---|---|---|
| Group 1 will be followed up by conservative management | This group will be followed up by close observation of GCS ,ct brain ,fundus examination \&may need Csf flowmetry | |
| Group 2 will undergo csf diversion | Csf diversion is either vp shunt or evd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Post traumatic Ventriculomegally How frequently does it require csf diversion ?
Ventricular enlargement is a common finding after severe head injury. This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss.
late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery .
Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation
Measured: From Dec 2024 to october 2025
Late Post traumatic Ventriculomegally How frequently does it require csf diversion ?
Ventricular enlargement is a common finding after severe head injury.This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss.
late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery.
Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation
Measured: December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nargis Samir Azmi Marqus, Assiut University
- Investigators
- Mohammed Elsayed mahmoud, Clinical Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703164
- Sponsor's protocol ID
- Post traumatic Hcp
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mazzini L, Campini R, Angelino E, Rognone F, Pastore I, Oliveri G. Posttraumatic hydrocephalus: a clinical, neuroradiologic, and neuropsychologic assessment of long-term outcome. Arch Phys Med Rehabil. 2003 Nov;84(11):1637-41. doi: 10.1053/s0003-9993(03)00314-9.
PubMed 14639563De Bonis P, Mangiola A, Pompucci A, Formisano R, Mattogno P, Anile C. CSF dynamics analysis in patients with post-traumatic ventriculomegaly. Clin Neurol Neurosurg. 2013 Jan;115(1):49-53. doi: 10.1016/j.clineuro.2012.04.012. Epub 2012 May 15.
PubMed 22595485Shah AH, Komotar RJ. Pathophysiology of acute hydrocephalus after subarachnoid hemorrhage. World Neurosurg. 2013 Sep-Oct;80(3-4):304-6. doi: 10.1016/j.wneu.2013.01.110. Epub 2013 Feb 1. No abstract available.
PubMed 23376378Choi I, Park HK, Chang JC, Cho SJ, Choi SK, Byun BJ. Clinical factors for the development of posttraumatic hydrocephalus after decompressive craniectomy. J Korean Neurosurg Soc. 2008 May;43(5):227-31. doi: 10.3340/jkns.2008.43.5.227. Epub 2008 May 20.
PubMed 19096601Williams JR, Meyer MR, Ricard JA, Sen R, Young CC, Feroze AH, Greil ME, Barros G, Durfy S, Hanak B, Morton RP, Temkin NR, Barber JK, Mac Donald CL, Chesnut RM. Re-examining decompressive craniectomy medial margin distance from midline as a metric for calculating the risk of post-traumatic hydrocephalus. J Clin Neurosci. 2021 May;87:125-131. doi: 10.1016/j.jocn.2021.02.025. Epub 2021 Mar 20.
PubMed 33863519De Bonis P, Pompucci A, Mangiola A, Rigante L, Anile C. Post-traumatic hydrocephalus after decompressive craniectomy: an underestimated risk factor. J Neurotrauma. 2010 Nov;27(11):1965-70. doi: 10.1089/neu.2010.1425.
PubMed 20812777Lu VM, Carlstrom LP, Perry A, Graffeo CS, Domingo RA, Young CC, Meyer FB. Prognostic significance of subdural hygroma for post-traumatic hydrocephalus after decompressive craniectomy in the traumatic brain injury setting: a systematic review and meta-analysis. Neurosurg Rev. 2021 Feb;44(1):129-138. doi: 10.1007/s10143-019-01223-z. Epub 2019 Dec 16.
PubMed 31845199Fattahian R, Bagheri SR, Sadeghi M. Development of Posttraumatic Hydrocephalus Requiring Ventriculoperitoneal Shunt After Decompressive Craniectomy for Traumatic Brain Injury: a Systematic Review and Meta-analysis of Retrospective Studies. Med Arch. 2018 Jun;72(3):214-219. doi: 10.5455/medarh.2018.72.214-219.
PubMed 30061770Hawkins TD, Lloyd AD, Fletcher GI, Hanka R. Ventricular size following head injury: a clinico-radiological study. Clin Radiol. 1976 Jul;27(3):279-89. doi: 10.1016/s0009-9260(76)80069-4.
PubMed 1086181Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Health. 2016 Dec;1(2):e76-e83. doi: 10.1016/S2468-2667(16)30017-2. Epub 2016 Nov 29.
PubMed 29253420
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Post Traumatic Ventriculomegally Does it Requires CSF Diversion ?
- ClinicalTrials.gov ID
- NCT06703164
- Acronym / sponsor ID
- Post traumatic Hcp
- Conditions
- Hydrocephalus, Ventriculomegally
- Keywords
- Post Traumatic Hcp
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 25 Nov 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.
Aim of the study is :
- prevelance of ventriculomegally in post traumatic patients after head trauma
- To determine the incidence of surgically treated ventriculomegally within 6 months from head injury in a series of consecutive adult patients undergoing acute head CT following injury.
- importance of csf diversion in post traumatic ventriculomegally
Detailed description
Ventricular enlargement is a common finding after severe head injury.This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss.[ late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury .
Its incidence deeply varies among series (0.7-50%), and this is mainly due to very different diagnostic criteria Therefore, given the very high number of patients with traumatic brain injury (TBIs), patients presenting with late post-traumatic ventriculomegally are not infrequent.
The choice of the term ventriculomegally in the title reflects the difficulty in differentiating a ventricular enlargement (secondary to post-traumatic brain damage with atrophy) from an active hydrocephalic process.
Those patients with subarachnoid hemorrhage (SAH) had a threefold risk of developing ventriculomegally compared to patients with no SAH during the 2-year follow-up period. Also, decompressive craniectomy and the presence of subdural hygroma after craniectomy seem to increase the risk for ventriculomegally.In craniectomy, the proximity of the craniotomy to the skull midline might increase the risk as well. Other possible risk factors for post traumatic ventriculomegaly include: increased age, cerebrospinal fuid infection, and intraventricular hemorrhage . Inflammation-mediated adhesions related to intracranial hemorrhages can explain the predisposition to post traumatic ventriculomegally.
In fact, practically all patients with post-traumatic ventricular enlargement present with symptoms of post-taumatic Lesions and almost never present with the Hakim-adams trriad. Some of them present nonspecific symptoms, especially arrested clinical improvement during rehabilitation programs, impaired consciousness or a worsening neurologic status .
A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery .
Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 will be followed up by conservative management | – | –This group will be followed up by close observation of GCS ,ct brain ,fundus examination \&may need Csf flowmetry |
| Group 2 will undergo csf diversion | – | –Csf diversion is either vp shunt or evd |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ventricular enlargement is a common finding after severe head injury.[1] This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss.[2] late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury The choice of the term ventriculomegally in the title reflects the difficulty in differentiating a ventricular enlargement (secondary to post-traumatic brain damage with atrophy) from an active hydrocephalic process. A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery [11,12]. Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation [13,14].
Key inclusion criteria (1 listed)
- All post traumatic patients showing ventriculomegally in ct brain f/u (2week to 6months) after trauma.
Key exclusion criteria (2 listed)
- 1.Any patient whose initial ct brain after head trauma showing ventriculomegally 2.any patient develops ventriculomegally within first 2 weeks of trauma or beyond 6 months of trauma.
- 3.any patient has hx of previous csf diversion .
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
Late Post traumatic Ventriculomegally How frequently does it require csf diversion ?
Time frame: From Dec 2024 to october 2025
Ventricular enlargement is a common finding after severe head injury. This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss. late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery . Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation
Late Post traumatic Ventriculomegally How frequently does it require csf diversion ?
Time frame: December 2024
Ventricular enlargement is a common finding after severe head injury.This is generally attributed to dysfunctional of perfusion and absorption of cerebrospinal fluid (CSF) or secondary to an atrophic process from neuronal loss. late post-traumatic ventriculomegally may be developed weeks to months after brain injury. Late post traumatic ventriculomegally incidence peaked within three months after injury A classic clinical feature to suspect post traumatic ventriculomegally after TBI is poor improvement or stagnation of recovery. Early recognition of post traumatic ventriculomegally is essential in the follow-up of patients with TBIs, as cerebrospinal fluid diversion (ventricular shunting) has been shown to improve outcome during rehabilitation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 14639563Mazzini L, Campini R, Angelino E, Rognone F, Pastore I, Oliveri G. Posttraumatic hydrocephalus: a clinical, neuroradiologic, and neuropsychologic assessment of long-term outcome. Arch Phys Med Rehabil. 2003 Nov;84(11):1637-41. doi: 10.1053/s0003-9993(03)00314-9.
- Results publication: PubMed 22595485De Bonis P, Mangiola A, Pompucci A, Formisano R, Mattogno P, Anile C. CSF dynamics analysis in patients with post-traumatic ventriculomegaly. Clin Neurol Neurosurg. 2013 Jan;115(1):49-53. doi: 10.1016/j.clineuro.2012.04.012. Epub 2012 May 15.
- Results publication: PubMed 23376378Shah AH, Komotar RJ. Pathophysiology of acute hydrocephalus after subarachnoid hemorrhage. World Neurosurg. 2013 Sep-Oct;80(3-4):304-6. doi: 10.1016/j.wneu.2013.01.110. Epub 2013 Feb 1. No abstract available.
- Results publication: PubMed 19096601Choi I, Park HK, Chang JC, Cho SJ, Choi SK, Byun BJ. Clinical factors for the development of posttraumatic hydrocephalus after decompressive craniectomy. J Korean Neurosurg Soc. 2008 May;43(5):227-31. doi: 10.3340/jkns.2008.43.5.227. Epub 2008 May 20.
- Results publication: PubMed 33863519Williams JR, Meyer MR, Ricard JA, Sen R, Young CC, Feroze AH, Greil ME, Barros G, Durfy S, Hanak B, Morton RP, Temkin NR, Barber JK, Mac Donald CL, Chesnut RM. Re-examining decompressive craniectomy medial margin distance from midline as a metric for calculating the risk of post-traumatic hydrocephalus. J Clin Neurosci. 2021 May;87:125-131. doi: 10.1016/j.jocn.2021.02.025. Epub 2021 Mar 20.
- Results publication: PubMed 20812777De Bonis P, Pompucci A, Mangiola A, Rigante L, Anile C. Post-traumatic hydrocephalus after decompressive craniectomy: an underestimated risk factor. J Neurotrauma. 2010 Nov;27(11):1965-70. doi: 10.1089/neu.2010.1425.
- Results publication: PubMed 31845199Lu VM, Carlstrom LP, Perry A, Graffeo CS, Domingo RA, Young CC, Meyer FB. Prognostic significance of subdural hygroma for post-traumatic hydrocephalus after decompressive craniectomy in the traumatic brain injury setting: a systematic review and meta-analysis. Neurosurg Rev. 2021 Feb;44(1):129-138. doi: 10.1007/s10143-019-01223-z. Epub 2019 Dec 16.
- Results publication: PubMed 30061770Fattahian R, Bagheri SR, Sadeghi M. Development of Posttraumatic Hydrocephalus Requiring Ventriculoperitoneal Shunt After Decompressive Craniectomy for Traumatic Brain Injury: a Systematic Review and Meta-analysis of Retrospective Studies. Med Arch. 2018 Jun;72(3):214-219. doi: 10.5455/medarh.2018.72.214-219.
- Results publication: PubMed 1086181Hawkins TD, Lloyd AD, Fletcher GI, Hanka R. Ventricular size following head injury: a clinico-radiological study. Clin Radiol. 1976 Jul;27(3):279-89. doi: 10.1016/s0009-9260(76)80069-4.
- Results publication: PubMed 29253420Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Health. 2016 Dec;1(2):e76-e83. doi: 10.1016/S2468-2667(16)30017-2. Epub 2016 Nov 29.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed Elsayed mahmoud, Clinical Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and Ventriculomegally, 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 2 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: opening soon, as of the sponsor's last update on 26 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nargis Samir Azmi, Resident doctor (01026842647 ext. 01220122861, nogas.azmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Post traumatic Ventriculomegally How frequently does it require csf diversion ? (time frame: From Dec 2024 to october 2025). The study lists 2 primary outcomes in all. 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 NCT06703164, which also lists 10 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 26 Nov 2024.