Aneurysmal Subarachnoid HemorrhageASTIMNCT06288659
aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
A study testing Intraventricular ICP monitoring-guided management in people with Aneurysmal Subarachnoid Hemorrhage and Intacranial Hypertension, run by Huashan Hospital at 1 site in China.
Trial summary
ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Intacranial Hypertension
- What is being tested?
- Intraventricular ICP monitoring-guided management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2024to 30 Oct 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset.
- Age ≥ 18 years.
- Symptom onset within 72 hours.
- Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging.
- Written informed consent obtained from the participant or legal representative.
Who cannot join
- Pregnancy or lactation;
- Bilateral fixed dilated pupils on admission;
- Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease;
- Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3;
- Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect;
- Subarachnoid haemorrhage caused by non-aneurysmal aetiologies;
Show all 11Show fewer
- Moyamoya disease associated aneurysmal rupture;
- Other underlying diseases expected to substantially affect prognosis;
- Active request for ICP monitoring by the patient or family;
- Any other condition considered unsuitable for enrolment by two investigators;
- Concurrent participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage.
Read the detailed description
Subarachnoid hemorrhage (SAH) is a severe type of cerebral hemorrhage, characterized by high mortality and disability rates. Approximately 85% of SAH cases are caused by ruptured intracranial aneurysms and are classified as aneurysmal SAH (aSAH). Improving the prognosis of patients with aSAH has become a pressing and significant issue.
The rupture of an aneurysm results in a significant amount of blood entering the subarachnoid space, triggering an increase in intracranial pressure (ICP). Elevated ICP can impair cerebral perfusion and contribute to secondary brain injury and poor functional outcomes. A systematic review and meta-analysis found that the incidence rate of elevated ICP (ICP >20 mmHg) in patients with aSAH was 70.69%, with elevated ICP being more common in patients with higher disease severity grades, including higher Hunt-Hess, WFNS, or modified Fisher grades.
Intraventricular ICP monitoring provides continuous, real-time quantitative ICP data and may facilitate a stepwise ICP-lowering strategy and goal-directed management based on quantitative ICP values. However, the role of continuous ICP monitoring and protocolized ICP-targeted management in aSAH remains uncertain, and high-quality randomized evidence remains limited. Given this evidence gap, this study was designed to determine whether a structured management strategy guided by continuous intraventricular ICP monitoring improves functional outcomes in patients with aSAH compared with standard care, and to assess the safety of this management strategy.
- Being tested
- Intraventricular ICP monitoring-guided management
- Keywords
- Aneurysmal subarachnoid hemorrhage, Intracranial pressure monitoring-guided management, Randomized controlled trial
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraventricular ICP monitoring-guided managementOther
The postoperative management of ICP is guided by continuous quantitative intraventricular ICP measurements according to a predefined ICP-targeted treatment protocol. The treatment target is ICP ≤20 mmHg, and a predefined stepwise ICP-lowering protocol is initiated if ICP remains >20 mmHg for more than 15 minutes. CSF drainage through the intraventricular catheter is permitted when clinically indicated. Other guideline-based treatments are provided in the same manner as in the control group.
| Study group | Role | What they receive |
|---|---|---|
| aSAH management guided by continuous intraventricular ICP monitoring | Experimental | In the acute phase of aSAH (following endovascular or microsurgical occlusion of the ruptured aneurysm), an intraventricular ICP catheter is placed for continuous ICP monitoring. Postoperative ICP management is guided by continuous quantitative ICP measurements according to a predefined ICP-targeted treatment protocol. Other guideline-based treatments are provided in the same manner as in the control group. Receives: Other: Intraventricular ICP monitoring-guided management |
| Guideline-based Standard Care Group | No intervention | Guideline-based standard aSAH management is provided without continuous intraventricular ICP monitoring or the predefined ICP-targeted treatment protocol. ICP-related management is not guided by continuous quantitative ICP measurements and is instead based on clinical assessment, imaging findings, and treating physician judgment. Clinically indicated CSF diversion and other standard ICP-lowering treatments are permitted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favourable functional outcome at 3 months
The proportion of patients with modified Rankin Scale (mRS) scores of 0-2. The mRS is an ordinal scale ranging from 0 to 6, with higher scores indicating greater disability. An mRS score of 0-2 is defined as a favourable functional outcome.
Measured: 3 months after ictus
Secondary outcomes (6)
Favourable functional outcome assessed by mRS
Proportion of patients with mRS scores 0-2
Measured: 1 month and 6 months after ictus
Favourable functional outcome assessed by Glasgow Outcome Scale-Extended (GOS-E)
The GOS-E is an ordinal scale ranging from 1 to 8, with lower scores indicating greater disability. A GOS-E score ≥5 is defined as a favourable functional outcome.
Measured: 1 month, 3 months, and 6 months after ictus
All-cause mortality
Proportion of patients who died.
Measured: 1 month, 3 months, and 6 months after ictus
Symptomatic hydrocephalus requiring permanent CSF shunting
Proportion of patients with symptomatic hydrocephalus requiring ventriculoperitoneal or lumboperitoneal shunt placement.
Measured: 3 months after ictus
Delayed cerebral ischemia (DCI)
Proportion of patients with DCI. DCI is defined according to the consensus criteria proposed by Vergouwen et al. Clinical DCI is defined as a new focal neurological impairment or a decrease of at least 2 points on the GCS, lasting for at least 1 hour, not apparent immediately after aneurysm occlusion, and not attributable to other causes. DCI-related cerebral infarction is defined as a new cerebral infarction identified on CT or MRI within 6 weeks after SAH that was absent on imaging obtained 24-48 hours after aneurysm occlusion and cannot be attributed to other causes.
Measured: 3 months after ictus
New-onset seizures
Proportion of patients with clinically or electroencephalographically confirmed new-onset seizures.
Measured: 3 months after ictus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start19 Jul 2024
- Primary completion29 Jul 2026
- Study completion30 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 Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhu, Huashan Hospital
- Investigators
- Wei Zhu, Ph.D., Principal investigator, Department of Neurosurgery, Huashan Hospital, Fudan UniversityXuehai Wu, Ph.D., Principal investigator, Department of Neurosurgery, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288659
- Sponsor's protocol ID
- KY2024-050
- Acronym
- ASTIM
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.
PubMed 20798370Claassen J, Park S. Spontaneous subarachnoid haemorrhage. Lancet. 2022 Sep 10;400(10355):846-862. doi: 10.1016/S0140-6736(22)00938-2. Epub 2022 Aug 16.
PubMed 35985353Macdonald RL, Schweizer TA. Spontaneous subarachnoid haemorrhage. Lancet. 2017 Feb 11;389(10069):655-666. doi: 10.1016/S0140-6736(16)30668-7. Epub 2016 Sep 13.
PubMed 27637674Etminan N, Chang HS, Hackenberg K, de Rooij NK, Vergouwen MDI, Rinkel GJE, Algra A. Worldwide Incidence of Aneurysmal Subarachnoid Hemorrhage According to Region, Time Period, Blood Pressure, and Smoking Prevalence in the Population: A Systematic Review and Meta-analysis. JAMA Neurol. 2019 May 1;76(5):588-597. doi: 10.1001/jamaneurol.2019.0006.
PubMed 30659573Neifert SN, Chapman EK, Martini ML, Shuman WH, Schupper AJ, Oermann EK, Mocco J, Macdonald RL. Aneurysmal Subarachnoid Hemorrhage: the Last Decade. Transl Stroke Res. 2021 Jun;12(3):428-446. doi: 10.1007/s12975-020-00867-0. Epub 2020 Oct 19.
PubMed 33078345Ironside N, Buell TJ, Chen CJ, Kumar JS, Paisan GM, Sokolowski JD, Liu KC, Ding D. High-Grade Aneurysmal Subarachnoid Hemorrhage: Predictors of Functional Outcome. World Neurosurg. 2019 May;125:e723-e728. doi: 10.1016/j.wneu.2019.01.162. Epub 2019 Feb 6.
PubMed 30735864Seule M, Oswald D, Muroi C, Brandi G, Keller E. Outcome, Return to Work and Health-Related Costs After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2020 Aug;33(1):49-57. doi: 10.1007/s12028-019-00905-2.
PubMed 31919809Hoh BL, Ko NU, Amin-Hanjani S, Chou SH-Y, Cruz-Flores S, Dangayach NS, Derdeyn CP, Du R, Hanggi D, Hetts SW, Ifejika NL, Johnson R, Keigher KM, Leslie-Mazwi TM, Lucke-Wold B, Rabinstein AA, Robicsek SA, Stapleton CJ, Suarez JI, Tjoumakaris SI, Welch BG. 2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2023 Jul;54(7):e314-e370. doi: 10.1161/STR.0000000000000436. Epub 2023 May 22.
PubMed 37212182Heuer GG, Smith MJ, Elliott JP, Winn HR, LeRoux PD. Relationship between intracranial pressure and other clinical variables in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Sep;101(3):408-16. doi: 10.3171/jns.2004.101.3.0408.
PubMed 15352597Robba C, Graziano F, Rebora P, Elli F, Giussani C, Oddo M, Meyfroidt G, Helbok R, Taccone FS, Prisco L, Vincent JL, Suarez JI, Stocchetti N, Citerio G; SYNAPSE-ICU Investigators. Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study. Lancet Neurol. 2021 Jul;20(7):548-558. doi: 10.1016/S1474-4422(21)00138-1.
PubMed 34146513
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT06288659
- Acronym / sponsor ID
- ASTIM / KY2024-050
- Keywords
- Aneurysmal subarachnoid hemorrhage, Intracranial pressure monitoring-guided management, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 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.
ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage.
Detailed description
Subarachnoid hemorrhage (SAH) is a severe type of cerebral hemorrhage, characterized by high mortality and disability rates. Approximately 85% of SAH cases are caused by ruptured intracranial aneurysms and are classified as aneurysmal SAH (aSAH). Improving the prognosis of patients with aSAH has become a pressing and significant issue.
The rupture of an aneurysm results in a significant amount of blood entering the subarachnoid space, triggering an increase in intracranial pressure (ICP). Elevated ICP can impair cerebral perfusion and contribute to secondary brain injury and poor functional outcomes. A systematic review and meta-analysis found that the incidence rate of elevated ICP (ICP >20 mmHg) in patients with aSAH was 70.69%, with elevated ICP being more common in patients with higher disease severity grades, including higher Hunt-Hess, WFNS, or modified Fisher grades.
Intraventricular ICP monitoring provides continuous, real-time quantitative ICP data and may facilitate a stepwise ICP-lowering strategy and goal-directed management based on quantitative ICP values. However, the role of continuous ICP monitoring and protocolized ICP-targeted management in aSAH remains uncertain, and high-quality randomized evidence remains limited. Given this evidence gap, this study was designed to determine whether a structured management strategy guided by continuous intraventricular ICP monitoring improves functional outcomes in patients with aSAH compared with standard care, and to assess the safety of this management strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aSAH management guided by continuous intraventricular ICP monitoring | Experimental | Other: Intraventricular ICP monitoring-guided managementIn the acute phase of aSAH (following endovascular or microsurgical occlusion of the ruptured aneurysm), an intraventricular ICP catheter is placed for continuous ICP monitoring. Postoperative ICP management is guided by continuous quantitative ICP measurements according to a predefined ICP-targeted treatment protocol. Other guideline-based treatments are provided in the same manner as in the control group. |
| Guideline-based Standard Care Group | No intervention | –Guideline-based standard aSAH management is provided without continuous intraventricular ICP monitoring or the predefined ICP-targeted treatment protocol. ICP-related management is not guided by continuous quantitative ICP measurements and is instead based on clinical assessment, imaging findings, and treating physician judgment. Clinically indicated CSF diversion and other standard ICP-lowering treatments are permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset.
- Age ≥ 18 years.
- Symptom onset within 72 hours.
- Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging.
- Written informed consent obtained from the participant or legal representative.
Key exclusion criteria (11 listed)
- Pregnancy or lactation;
- Bilateral fixed dilated pupils on admission;
- Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease;
- Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3;
- Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect;
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 |
|---|---|---|
| Intraventricular ICP monitoring-guided managementThe postoperative management of ICP is guided by continuous quantitative intraventricular ICP measurements according to a predefined ICP-targeted treatment protocol. The treatment target is ICP ≤20 mmHg, and a predefined stepwise ICP-lowering protocol is initiated if ICP remains >20 mmHg for more than 15 minutes. CSF drainage through the intraventricular catheter is permitted when clinically indicated. Other guideline-based treatments are provided in the same manner as in the control group. | Other | aSAH management guided by continuous intraventricular ICP monitoring |
Primary outcome
Favourable functional outcome at 3 months
Time frame: 3 months after ictus
The proportion of patients with modified Rankin Scale (mRS) scores of 0-2. The mRS is an ordinal scale ranging from 0 to 6, with higher scores indicating greater disability. An mRS score of 0-2 is defined as a favourable functional outcome.
6 secondary outcomes
Favourable functional outcome assessed by mRS
Time frame: 1 month and 6 months after ictus
Favourable functional outcome assessed by Glasgow Outcome Scale-Extended (GOS-E)
Time frame: 1 month, 3 months, and 6 months after ictus
All-cause mortality
Time frame: 1 month, 3 months, and 6 months after ictus
Symptomatic hydrocephalus requiring permanent CSF shunting
Time frame: 3 months after ictus
Delayed cerebral ischemia (DCI)
Time frame: 3 months after ictus
New-onset seizures
Time frame: 3 months after ictus
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 28 Sep 2026.
- Background: PubMed 20798370Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.
- Background: PubMed 35985353Claassen J, Park S. Spontaneous subarachnoid haemorrhage. Lancet. 2022 Sep 10;400(10355):846-862. doi: 10.1016/S0140-6736(22)00938-2. Epub 2022 Aug 16.
- Background: PubMed 27637674Macdonald RL, Schweizer TA. Spontaneous subarachnoid haemorrhage. Lancet. 2017 Feb 11;389(10069):655-666. doi: 10.1016/S0140-6736(16)30668-7. Epub 2016 Sep 13.
- Background: PubMed 30659573Etminan N, Chang HS, Hackenberg K, de Rooij NK, Vergouwen MDI, Rinkel GJE, Algra A. Worldwide Incidence of Aneurysmal Subarachnoid Hemorrhage According to Region, Time Period, Blood Pressure, and Smoking Prevalence in the Population: A Systematic Review and Meta-analysis. JAMA Neurol. 2019 May 1;76(5):588-597. doi: 10.1001/jamaneurol.2019.0006.
- Background: PubMed 33078345Neifert SN, Chapman EK, Martini ML, Shuman WH, Schupper AJ, Oermann EK, Mocco J, Macdonald RL. Aneurysmal Subarachnoid Hemorrhage: the Last Decade. Transl Stroke Res. 2021 Jun;12(3):428-446. doi: 10.1007/s12975-020-00867-0. Epub 2020 Oct 19.
- Background: PubMed 30735864Ironside N, Buell TJ, Chen CJ, Kumar JS, Paisan GM, Sokolowski JD, Liu KC, Ding D. High-Grade Aneurysmal Subarachnoid Hemorrhage: Predictors of Functional Outcome. World Neurosurg. 2019 May;125:e723-e728. doi: 10.1016/j.wneu.2019.01.162. Epub 2019 Feb 6.
- Background: PubMed 31919809Seule M, Oswald D, Muroi C, Brandi G, Keller E. Outcome, Return to Work and Health-Related Costs After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2020 Aug;33(1):49-57. doi: 10.1007/s12028-019-00905-2.
- Background: PubMed 37212182Hoh BL, Ko NU, Amin-Hanjani S, Chou SH-Y, Cruz-Flores S, Dangayach NS, Derdeyn CP, Du R, Hanggi D, Hetts SW, Ifejika NL, Johnson R, Keigher KM, Leslie-Mazwi TM, Lucke-Wold B, Rabinstein AA, Robicsek SA, Stapleton CJ, Suarez JI, Tjoumakaris SI, Welch BG. 2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2023 Jul;54(7):e314-e370. doi: 10.1161/STR.0000000000000436. Epub 2023 May 22.
- Background: PubMed 15352597Heuer GG, Smith MJ, Elliott JP, Winn HR, LeRoux PD. Relationship between intracranial pressure and other clinical variables in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Sep;101(3):408-16. doi: 10.3171/jns.2004.101.3.0408.
- Background: PubMed 34146513Robba C, Graziano F, Rebora P, Elli F, Giussani C, Oddo M, Meyfroidt G, Helbok R, Taccone FS, Prisco L, Vincent JL, Suarez JI, Stocchetti N, Citerio G; SYNAPSE-ICU Investigators. Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study. Lancet Neurol. 2021 Jul;20(7):548-558. doi: 10.1016/S1474-4422(21)00138-1.
- 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.
Wei Zhu, Ph.D. principal investigator
Department of Neurosurgery, Huashan Hospital, Fudan University
Xuehai Wu, Ph.D. principal investigator
Department of Neurosurgery, Huashan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraventricular ICP monitoring-guided management in people with Aneurysmal Subarachnoid Hemorrhage and Intacranial Hypertension, run by Huashan Hospital at 1 site in China.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. 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 China. 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?
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?
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?
Favourable functional outcome at 3 months (time frame: 3 months after ictus). 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 NCT06288659, 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 28 Sep 2026.