Subarachnoid HemorrhagePVENCT04193124
Prolonged Vasospasm in Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Vasospasm, Intracranial, run by Hospital El Cruce.
Trial summary
The prevalence and clinical implications of prolonged cerebral vasospasm in patients with subarachnoid hemorrhage are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
- What is being tested?
- transcranial doppler.
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2019
- How long will I take part?
- 6 Months
- 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: Patients with subarachnoid hemorrhage and vasospasm
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Clinical Implication of Prolonged Vasospasm in Subarachnoid Hemorrhage
The prevalence and clinical implications of prolonged cerebral vasospasm in patients with subarachnoid hemorrhage are unknown.
Read the detailed description
The prevalence and clinical importance of prolonged cerebral vasospasm (after day 21 of bleeding) in patients with subarachnoid hemorrhage is unknown.
Objectives: To determine the prevalence and clinical relevance of prolonged vasospasm in patients with subarachnoid hemorrhage secondary to cerebral aneurysm.
A prospective and observational study was conducted. Adult patients with a diagnosis of subarcnoid hemorrhage CT scan or presence of blood in the cerebrospinal fluid were incorporated. Patients with vasospasm were followed daily with transcranial doppler. Those with technical impossibility to perform transcranial and pregnant Doppler were excluded. Day 0 was defined, the day of the last bleeding.
Evaluation: 1) It was considered in patients with prolonged vasospasm: whether or not it was associated with clinical manifestation (deterioration of the sensory or new neurological deficit) and 2) the magnitude of the vasospasm (mild, moderate or severe) was measured by transcranial doppler.
- Conditions
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
- Being tested
- transcranial doppler.
- Keywords
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Transcranial doppler
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial doppler.Diagnostic test
Daily monitoring of transcranial doppler until the disappearance of the intracranial vasosparm
| Study group | Role | What they receive |
|---|---|---|
| Prolonged vasospasm | Adult patients with a diagnosis of subarcnoid hemorrhage CT scan or presence of blood in the cerebrospinal fluid were incorporated. Patients with vasospasm were followed daily with transcranial doppler. Prolonged vasospasm was defined for patients who persisted with vasospasm after day 21 of cerebral bleeding. Receives: Diagnostic Test: transcranial doppler. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical implication
Presence or not of neurological symptoms related to intracranial vasospasm (delayed cerebral ischemia)
Measured: 1 month
Gravity of vasospasm by transcranial doppler
Mild, moderate and severe according to Aaslid scale
Measured: 1 month
Secondary outcomes (1)
Mortality assessment
Mortality was assessed at hospital discharge and at six months
Measured: six monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study startApr 2015
- Primary completionJan 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193124
- Sponsor's protocol ID
- HEC
- Acronym
- PVE
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harders AG, Gilsbach JM. Time course of blood velocity changes related to vasospasm in the circle of Willis measured by transcranial Doppler ultrasound. J Neurosurg. 1987 May;66(5):718-28. doi: 10.3171/jns.1987.66.5.0718.
PubMed 3553456MASPES PE, MARINI G. Intracranial arterial spasm related to supraclinoid ruptured aneurysms. Acta Neurochir (Wien). 1962 Dec 12;10:630-8. doi: 10.1007/BF01406192. No abstract available.
PubMed 13933363Yamaguchi M, Bun T, Kuwahara T, Kitamura S. Very late-onset symptomatic cerebral vasospasm caused by a large residual aneurysmal subarachnoid hematoma--case report. Neurol Med Chir (Tokyo). 1999 Sep;39(9):677-80. doi: 10.2176/nmc.39.677.
PubMed 10563118Muller M, Schwerdtfeger K, Zieroth S. Assessment of middle cerebral artery diameter after aneurysmal subarachnoid hemorrhage by transcranial color-coded duplex sonography. Eur J Ultrasound. 2000 Mar;11(1):15-9. doi: 10.1016/s0929-8266(99)00066-x.
PubMed 10717509
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implication of Prolonged Vasospasm in Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT04193124
- Acronym / sponsor ID
- PVE / HEC
- Conditions
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
- Keywords
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Transcranial doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Dec 2019 (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 prevalence and clinical implications of prolonged cerebral vasospasm in patients with subarachnoid hemorrhage are unknown.
Detailed description
The prevalence and clinical importance of prolonged cerebral vasospasm (after day 21 of bleeding) in patients with subarachnoid hemorrhage is unknown.
Objectives: To determine the prevalence and clinical relevance of prolonged vasospasm in patients with subarachnoid hemorrhage secondary to cerebral aneurysm.
A prospective and observational study was conducted. Adult patients with a diagnosis of subarcnoid hemorrhage CT scan or presence of blood in the cerebrospinal fluid were incorporated. Patients with vasospasm were followed daily with transcranial doppler. Those with technical impossibility to perform transcranial and pregnant Doppler were excluded. Day 0 was defined, the day of the last bleeding.
Evaluation: 1) It was considered in patients with prolonged vasospasm: whether or not it was associated with clinical manifestation (deterioration of the sensory or new neurological deficit) and 2) the magnitude of the vasospasm (mild, moderate or severe) was measured by transcranial doppler.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged vasospasm | – | Diagnostic Test: transcranial doppler.Adult patients with a diagnosis of subarcnoid hemorrhage CT scan or presence of blood in the cerebrospinal fluid were incorporated. Patients with vasospasm were followed daily with transcranial doppler. Prolonged vasospasm was defined for patients who persisted with vasospasm after day 21 of cerebral bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subarachnoid hemorrhage and vasospasm
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| transcranial doppler.Daily monitoring of transcranial doppler until the disappearance of the intracranial vasosparm | Diagnostic test | Prolonged vasospasm |
Primary outcome
Clinical implication
Time frame: 1 month
Presence or not of neurological symptoms related to intracranial vasospasm (delayed cerebral ischemia)
Gravity of vasospasm by transcranial doppler
Time frame: 1 month
Mild, moderate and severe according to Aaslid scale
1 secondary outcome
Mortality assessment
Time frame: six monts
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 10 Dec 2019.
- Results publication: PubMed 3553456Harders AG, Gilsbach JM. Time course of blood velocity changes related to vasospasm in the circle of Willis measured by transcranial Doppler ultrasound. J Neurosurg. 1987 May;66(5):718-28. doi: 10.3171/jns.1987.66.5.0718.
- Results publication: PubMed 13933363MASPES PE, MARINI G. Intracranial arterial spasm related to supraclinoid ruptured aneurysms. Acta Neurochir (Wien). 1962 Dec 12;10:630-8. doi: 10.1007/BF01406192. No abstract available.
- Results publication: PubMed 10563118Yamaguchi M, Bun T, Kuwahara T, Kitamura S. Very late-onset symptomatic cerebral vasospasm caused by a large residual aneurysmal subarachnoid hematoma--case report. Neurol Med Chir (Tokyo). 1999 Sep;39(9):677-80. doi: 10.2176/nmc.39.677.
- Results publication: PubMed 10717509Muller M, Schwerdtfeger K, Zieroth S. Assessment of middle cerebral artery diameter after aneurysmal subarachnoid hemorrhage by transcranial color-coded duplex sonography. Eur J Ultrasound. 2000 Mar;11(1):15-9. doi: 10.1016/s0929-8266(99)00066-x.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Vasospasm, Intracranial, run by Hospital El Cruce.
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 0 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: finished, as of the sponsor's last update on 10 Dec 2019. 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?
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?
Clinical implication (time frame: 1 month). 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 NCT04193124, which also lists 4 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 10 Dec 2019.