Subarachnoid HemorrhageEarlyVPSNCT04567277
Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage
A study testing External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS) in people with Subarachnoid Hemorrhage and Ventriculo-Peritoneal Shunt Infection, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Acute hydrocephalus is a common complication following subarachnoid hemorrhage (SAH). Early and emergency insertion of external ventricular drain (EVD) is standard treatment of acute post-SAH hydrocephalus. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Ventriculo-Peritoneal Shunt Infection, Hydrocephalus
- What is being tested?
- External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Jan 2017to Mar 2021
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with SAH and World Federation of Neurosurgeon (WFNS) Grade 4 or 5 and
- patient who underwent ventriculostomy (EVD insertion) within 24 hours of SAH onset.
Who cannot join
- patients with Glasgow Coma Scale of (GCS) 3 and fixed non-reactive pupils,
- patients in whom EVD was inserted in the other hospital,
- patients were successfully weaned from EVD with 7-10 days of EVD insertion
- patients who died during hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Acute hydrocephalus is a common complication following subarachnoid hemorrhage (SAH). Early and emergency insertion of external ventricular drain (EVD) is standard treatment of acute post-SAH hydrocephalus. According to the high risk of infection associated with EVD, the study evaluates the outcome of early EVD conversion to ventriculoperitoneal shunt (VPS) in poor-grade SAH patients.
Read the detailed description
This study was performed on patients diagnosed with high grade SAH (WFNS 4-5) who undergo EVD within 24 hours of their admission. The conversion of EVD to VPS is performed within 7-10 days of EVD insertion, defined as early VPS group. The ventricular catheter is inserted in lateral ventricle using the same burr hole of EVD or the contralateral Kocher's point. All ruptured aneurysms could be closed by endovascular techniques or surgery.
The goal is to discontinuing EVD or its conversion to VPS within 7 to 10 days of insertion. At day 5-7 of EVD insertion, the EVD level is elevated from 15 cmH2O to 25 centimeter of water (cmH2O) gradually. The patients is evaluated during the 48 hours for cerebrospinal fluid (CSF) volume discharge, neurological consciousness, and hydrocephalus within brain CT scan acquired at the end of 48 hours of observation. If the daily CSF fluid discharge will be greater than 100 ml, brain CT scan shows evidence of HCP, there is any CSF leak from around the catheter, or the patient experiences GCS drop for 2 points or more, EVD is converted to VPS.
EVD conversion to VPS is postponed if there is any evidence of CSF infection within the last CSF analysis obtained 48 hours before VPS placement, patient experiences fever (>38.5° C) without any other source, or there is any evidence of severe vasospasm in transcranial Doppler (TCD) imaging or brain CT angiography. Otherwise, The EVD is discontinued.
For all patients, a brain CT scan is taken to evaluate the location of shunt 24 hours after VPS placement. Forty-eight hours after VPS placement, lumbar puncture (LP) is performed to collect CSF for ruling out the possibility of shunt infection or ventriculitis. Shunt malfunction (approved by imaging or signs of HCP) is reported if it occurred within 3 months of VPS placement.
When VPS malfunction is diagnosed it is revised. CSF infection is considered if there is a positive culture or ratio of CSF white blood cell count (WBC)/ red blood cell count (RBC) to blood WBC/RBC was more than 3. All patients is evaluated for clinical condition using modified Rankin scale (mRs) at discharge and 6 months later.
- Being tested
- External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)
- Keywords
- High grade subarachnoid hemorrhage, External ventricular drainage, Ventricular-peritoneal shunt
- Medical subject headings
- Subarachnoid Hemorrhage, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)Procedure or surgery
EVD in high grade SAH patients were converted into VPS with 7-10 days of EVD insertion
| Study group | Role | What they receive |
|---|---|---|
| Early VPS | Experimental | Not described Receives: Procedure: External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of ventriculo-peritoneal malfunction
VPS is defined malfunction when signs of hydrocephalus are seen in imaging (CTS or MRI)/clinical findings
Measured: 3 months
rate of ventricle-peritoneal infection
Measured: 3 months
Secondary outcomes (1)
RBC / protein level in CSF association with VPS malfunction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study startJan 2017
- Primary completionFeb 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study has a single group including patients with high grade subarachnoid hemorrhage (WFNS 3-4) for whom EVD was inserted. EVD was tried converted into VPS within 7-10 days of insertion.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humain Baharvahdat, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567277
- Sponsor's protocol ID
- T5097
- Acronym
- EarlyVPS
- Status last verified
- Mar 2022
- First submitted
- 23 Sep 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage
- ClinicalTrials.gov ID
- NCT04567277
- Acronym / sponsor ID
- EarlyVPS / T5097
- Keywords
- High grade subarachnoid hemorrhage, External ventricular drainage, Ventricular-peritoneal shunt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 28 Sep 2020 (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.
Acute hydrocephalus is a common complication following subarachnoid hemorrhage (SAH). Early and emergency insertion of external ventricular drain (EVD) is standard treatment of acute post-SAH hydrocephalus. According to the high risk of infection associated with EVD, the study evaluates the outcome of early EVD conversion to ventriculoperitoneal shunt (VPS) in poor-grade SAH patients.
Detailed description
This study was performed on patients diagnosed with high grade SAH (WFNS 4-5) who undergo EVD within 24 hours of their admission. The conversion of EVD to VPS is performed within 7-10 days of EVD insertion, defined as early VPS group. The ventricular catheter is inserted in lateral ventricle using the same burr hole of EVD or the contralateral Kocher's point. All ruptured aneurysms could be closed by endovascular techniques or surgery.
The goal is to discontinuing EVD or its conversion to VPS within 7 to 10 days of insertion. At day 5-7 of EVD insertion, the EVD level is elevated from 15 cmH2O to 25 centimeter of water (cmH2O) gradually. The patients is evaluated during the 48 hours for cerebrospinal fluid (CSF) volume discharge, neurological consciousness, and hydrocephalus within brain CT scan acquired at the end of 48 hours of observation. If the daily CSF fluid discharge will be greater than 100 ml, brain CT scan shows evidence of HCP, there is any CSF leak from around the catheter, or the patient experiences GCS drop for 2 points or more, EVD is converted to VPS.
EVD conversion to VPS is postponed if there is any evidence of CSF infection within the last CSF analysis obtained 48 hours before VPS placement, patient experiences fever (>38.5° C) without any other source, or there is any evidence of severe vasospasm in transcranial Doppler (TCD) imaging or brain CT angiography. Otherwise, The EVD is discontinued.
For all patients, a brain CT scan is taken to evaluate the location of shunt 24 hours after VPS placement. Forty-eight hours after VPS placement, lumbar puncture (LP) is performed to collect CSF for ruling out the possibility of shunt infection or ventriculitis. Shunt malfunction (approved by imaging or signs of HCP) is reported if it occurred within 3 months of VPS placement.
When VPS malfunction is diagnosed it is revised. CSF infection is considered if there is a positive culture or ratio of CSF white blood cell count (WBC)/ red blood cell count (RBC) to blood WBC/RBC was more than 3. All patients is evaluated for clinical condition using modified Rankin scale (mRs) at discharge and 6 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study has a single group including patients with high grade subarachnoid hemorrhage (WFNS 3-4) for whom EVD was inserted. EVD was tried converted into VPS within 7-10 days of insertion.
| Arm | Type | Receives |
|---|---|---|
| Early VPS | Experimental | Procedure: External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with SAH and World Federation of Neurosurgeon (WFNS) Grade 4 or 5 and
- patient who underwent ventriculostomy (EVD insertion) within 24 hours of SAH onset.
Key exclusion criteria (4 listed)
- patients with Glasgow Coma Scale of (GCS) 3 and fixed non-reactive pupils,
- patients in whom EVD was inserted in the other hospital,
- patients were successfully weaned from EVD with 7-10 days of EVD insertion
- patients who died during hospitalization.
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 |
|---|---|---|
| External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)EVD in high grade SAH patients were converted into VPS with 7-10 days of EVD insertion | Procedure or surgery | Early VPS |
Primary outcome
rate of ventriculo-peritoneal malfunction
Time frame: 3 months
VPS is defined malfunction when signs of hydrocephalus are seen in imaging (CTS or MRI)/clinical findings
rate of ventricle-peritoneal infection
Time frame: 3 months
1 secondary outcome
RBC / protein level in CSF association with VPS malfunction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS) in people with Subarachnoid Hemorrhage and Ventriculo-Peritoneal Shunt Infection, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Mar 2022. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of ventriculo-peritoneal malfunction (time frame: 3 months). 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?
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 18 Mar 2022.