Aneurysmal Subarachnoid HemorrhageEPIC-SAHNCT07149922
Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage
A study testing Blood pressure was regulated within the normal target management range and Blood pressure was regulated within the elevated target management range in people with Aneurysmal Subarachnoid Hemorrhage and Aneurysmal Subarachnoid Hemorrhage (aSAH), run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if elevating postoperative blood pressure works to improve prognosis in aneurysmal subarachnoid hemorrhage (aSAH) patients. The main questions it aims to answer are: Does elevating postoperative blood pressure can improve the prognosis of aSAH ? What safety problems do… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage (aSAH)
- What is being tested?
- Blood pressure was regulated within the normal target management range and Blood pressure was regulated within the elevated target management range
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Jul 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Aged 18-75 years;
- 2) Patients who underwent clipping or endovascular intervention within 72 hours post-ictus;
- 3) Intracranial aneurysm diagnosis confirmed by operating surgeons (including neurosurgeons or neurointerventionalists) through imaging findings, intraoperative visualization, or angiography, with subarachnoid hemorrhage (SAH) attributable to the ruptured aneurysm lesion (verified via imaging, xanthochromic cerebrospinal fluid, or intraoperative observation);
- 4) Hunt-Hess grade 1-4 at onset;
Who cannot join
- 1) Presence of untreated intracranial aneurysms with rupture risk;
- 2) Moderate-to-severe cerebral vasospasm confirmed by pre-enrollment digital subtraction angiography (DSA), transcranial Doppler (TCD), or computed tomography angiography (CTA);
- 3) Intracranial massive hematoma (e.g., volume >30 mL with midline shift >5 mm) causing severe cerebral herniation, as evidenced by admission CT or other imaging modalities;
- 4) Prior cranial neurosurgery for other central nervous system disorders;
- 5) Comorbid major systemic diseases or multi-organ dysfunction with life expectancy <1 year, potentially compromising study implementation or follow-up observations;
- 6) Poorly controlled hypertension despite regular antihypertensive medication (e.g., systolic blood pressure >160 mmHg during pharmacotherapy);
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- 7) Pre-onset modified Rankin Scale (mRS) score >2 points, indicating disability from other causes;
- 8) Intraoperative major complications including but not limited to massive cerebral hemorrhage, hypovolemic shock, or malignant brain swelling;
- 9) Anticipated inability to complete scheduled follow-up assessments within 180 days;
- 10) Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 107000
Bingcheng Zhu, 18361561396, zhubingcheng327@163.com
About this study
The goal of this clinical trial is to learn if elevating postoperative blood pressure works to improve prognosis in aneurysmal subarachnoid hemorrhage (aSAH) patients. The main questions it aims to answer are:
Does elevating postoperative blood pressure can improve the prognosis of aSAH ? What safety problems do participants have when received elevating blood pressure measurement?
Participants will:
Receive elevating or lowering blood pressure therapy in 72 hours after randomization, in order to maintain blood pressure within predefined target ranges Receive follow-up at 30 days, 90 days, and 180 days after randomization
- Being tested
- Blood pressure was regulated within the normal target management range, Blood pressure was regulated within the elevated target management range
- Keywords
- aneurysmal subarachnoid hemorrhage, delayed cerebral ischemia, blood pressure, prognosis
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure was regulated within the normal target management rangeOther
Also called normal target blood pressure management
Blood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <120 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 120-160 mmHg (<160 mmHg and >120 mmHg). For SBP >160 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 120-160 mmHg, standard supportive care was provided.
Blood pressure was regulated within the elevated target management rangeOther
Also called elevated target blood pressure
Blood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <160 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 160-180 mmHg ( ≥160 mmHg and ≤120 mmHg). For SBP >180 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 160-180 mmHg, standard supportive care was provided.
| Study group | Role | What they receive |
|---|---|---|
| Normal Target Blood Pressure | Active comparator | Blood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <120 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 120-160 mmHg (<160 mmHg and >120 mmHg). For SBP >160 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 120-160 mmHg, standard supportive care was provided. Receives: Other: Blood pressure was regulated within the normal target management range |
| Elevated Target Blood Pressure | Experimental | Blood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <160 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 160-180 mmHg (≤160 mmHg and ≥120 mmHg). For SBP >180 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 160-180 mmHg range. For SBP within the range of 160-180 mmHg, standard supportive care was provided. Receives: Other: Blood pressure was regulated within the elevated target management range |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
The modified Rankin Scale (mRS), a scale ranging from 0 (no symptoms) to 6 (death), is a precise and effective tool to assess the functional outcome of patients.
Measured: Patients received follow-up through telephone consultations or outpatient appointments in the 180 days after randomization. The functional outcome was assessed by the mRS at 90 days post-discharge. mRS 0-2 was considered as favorable clinical outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Beijing Tiantan 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Development Center for Medical Science & Technology National Health Commission of the People's Republic of China, Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Xiaolin Chen, MD, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149922
- Sponsor's protocol ID
- KY-2024-267-01
- Other IDs
- 2023ZD0505106
- Acronym
- EPIC-SAH
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect patient privacy, the decision was made not to share the data.
Publications
Marbacher S, Neuschmelting V, Andereggen L, Widmer HR, von Gunten M, Takala J, Jakob SM, Fandino J. Early brain injury linearly correlates with reduction in cerebral perfusion pressure during the hyperacute phase of subarachnoid hemorrhage. Intensive Care Med Exp. 2014 Dec;2(1):30. doi: 10.1186/s40635-014-0030-1. Epub 2014 Nov 30.
PubMed 26266927Tagami T, Kuwamoto K, Watanabe A, Unemoto K, Yokobori S, Matsumoto G, Igarashi Y, Yokota H; SAH PiCCO Study Group. Effect of triple-h prophylaxis on global end-diastolic volume and clinical outcomes in patients with aneurysmal subarachnoid hemorrhage. Neurocrit Care. 2014 Dec;21(3):462-9. doi: 10.1007/s12028-014-9973-z.
PubMed 24865266Wang J, Lin F, Zeng M, Liu M, Zheng M, Ren Y, Li S, Yang X, Chen Y, Chen X, Sessler DI, Peng Y. Intraoperative blood pressure and cardiac complications after aneurysmal subarachnoid hemorrhage: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):965-973. doi: 10.1097/JS9.0000000000000928.
PubMed 38016131Shah VA, Gonzalez LF, Suarez JI. Therapies for Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2023 Aug;39(1):36-50. doi: 10.1007/s12028-023-01747-9. Epub 2023 May 25.
PubMed 37231236Minhas JS, Moullaali TJ, Rinkel GJE, Anderson CS. Blood Pressure Management After Intracerebral and Subarachnoid Hemorrhage: The Knowns and Known Unknowns. Stroke. 2022 Apr;53(4):1065-1073. doi: 10.1161/STROKEAHA.121.036139. Epub 2022 Mar 8.
PubMed 35255708
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT07149922
- Acronym / sponsor ID
- EPIC-SAH / KY-2024-267-01
- Keywords
- aneurysmal subarachnoid hemorrhage, delayed cerebral ischemia, blood pressure, prognosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Development Center for Medical Science & Technology National Health Commission of the People's Republic of China, Tianjin Medical University General Hospital
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Sep 2025 (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 goal of this clinical trial is to learn if elevating postoperative blood pressure works to improve prognosis in aneurysmal subarachnoid hemorrhage (aSAH) patients. The main questions it aims to answer are:
Does elevating postoperative blood pressure can improve the prognosis of aSAH ? What safety problems do participants have when received elevating blood pressure measurement?
Participants will:
Receive elevating or lowering blood pressure therapy in 72 hours after randomization, in order to maintain blood pressure within predefined target ranges Receive follow-up at 30 days, 90 days, and 180 days after randomization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Target Blood Pressure | Active comparator | Other: Blood pressure was regulated within the normal target management rangeBlood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <120 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 120-160 mmHg (<160 mmHg and >120 mmHg). For SBP >160 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 120-160 mmHg, standard supportive care was provided. |
| Elevated Target Blood Pressure | Experimental | Other: Blood pressure was regulated within the elevated target management rangeBlood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <160 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 160-180 mmHg (≤160 mmHg and ≥120 mmHg). For SBP >180 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 160-180 mmHg range. For SBP within the range of 160-180 mmHg, standard supportive care was provided. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) Aged 18-75 years;
- 2) Patients who underwent clipping or endovascular intervention within 72 hours post-ictus;
- 3) Intracranial aneurysm diagnosis confirmed by operating surgeons (including neurosurgeons or neurointerventionalists) through imaging findings, intraoperative visualization, or angiography, with subarachnoid hemorrhage (SAH) attributable to the ruptured aneurysm lesion (verified via imaging, xanthochromic cerebrospinal fluid, or intraoperative observation);
- 4) Hunt-Hess grade 1-4 at onset;
Key exclusion criteria (10 listed)
- 1) Presence of untreated intracranial aneurysms with rupture risk;
- 2) Moderate-to-severe cerebral vasospasm confirmed by pre-enrollment digital subtraction angiography (DSA), transcranial Doppler (TCD), or computed tomography angiography (CTA);
- 3) Intracranial massive hematoma (e.g., volume >30 mL with midline shift >5 mm) causing severe cerebral herniation, as evidenced by admission CT or other imaging modalities;
- 4) Prior cranial neurosurgery for other central nervous system disorders;
- 5) Comorbid major systemic diseases or multi-organ dysfunction with life expectancy <1 year, potentially compromising study implementation or follow-up observations;
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 |
|---|---|---|
| Blood pressure was regulated within the normal target management rangeAlso: normal target blood pressure managementBlood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <120 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 120-160 mmHg (<160 mmHg and >120 mmHg). For SBP >160 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 120-160 mmHg, standard supportive care was provided. | Other | Normal Target Blood Pressure |
| Blood pressure was regulated within the elevated target management rangeAlso: elevated target blood pressureBlood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <160 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 160-180 mmHg ( ≥160 mmHg and ≤120 mmHg). For SBP >180 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 160-180 mmHg, standard supportive care was provided. | Other | Elevated Target Blood Pressure |
Primary outcome
Functional outcome
Time frame: Patients received follow-up through telephone consultations or outpatient appointments in the 180 days after randomization. The functional outcome was assessed by the mRS at 90 days post-discharge. mRS 0-2 was considered as favorable clinical outcome.
The modified Rankin Scale (mRS), a scale ranging from 0 (no symptoms) to 6 (death), is a precise and effective tool to assess the functional outcome of patients.
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 2 Sep 2025.
- Background: PubMed 26266927Marbacher S, Neuschmelting V, Andereggen L, Widmer HR, von Gunten M, Takala J, Jakob SM, Fandino J. Early brain injury linearly correlates with reduction in cerebral perfusion pressure during the hyperacute phase of subarachnoid hemorrhage. Intensive Care Med Exp. 2014 Dec;2(1):30. doi: 10.1186/s40635-014-0030-1. Epub 2014 Nov 30.
- Background: PubMed 24865266Tagami T, Kuwamoto K, Watanabe A, Unemoto K, Yokobori S, Matsumoto G, Igarashi Y, Yokota H; SAH PiCCO Study Group. Effect of triple-h prophylaxis on global end-diastolic volume and clinical outcomes in patients with aneurysmal subarachnoid hemorrhage. Neurocrit Care. 2014 Dec;21(3):462-9. doi: 10.1007/s12028-014-9973-z.
- Background: PubMed 38016131Wang J, Lin F, Zeng M, Liu M, Zheng M, Ren Y, Li S, Yang X, Chen Y, Chen X, Sessler DI, Peng Y. Intraoperative blood pressure and cardiac complications after aneurysmal subarachnoid hemorrhage: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):965-973. doi: 10.1097/JS9.0000000000000928.
- Background: PubMed 37231236Shah VA, Gonzalez LF, Suarez JI. Therapies for Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2023 Aug;39(1):36-50. doi: 10.1007/s12028-023-01747-9. Epub 2023 May 25.
- Background: PubMed 35255708Minhas JS, Moullaali TJ, Rinkel GJE, Anderson CS. Blood Pressure Management After Intracerebral and Subarachnoid Hemorrhage: The Knowns and Known Unknowns. Stroke. 2022 Apr;53(4):1065-1073. doi: 10.1161/STROKEAHA.121.036139. Epub 2022 Mar 8.
- Individual participant dataSharing planned: No. To protect patient privacy, the decision was made not to share the data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure was regulated within the normal target management range and Blood pressure was regulated within the elevated target management range in people with Aneurysmal Subarachnoid Hemorrhage and Aneurysmal Subarachnoid Hemorrhage (aSAH), run by Beijing Tiantan 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 4 inclusion and 10 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 2 Sep 2025. 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?
Contact Bingcheng Zhu, Doctor (86-18361561396, zhubingcheng327@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: Patients received follow-up through telephone consultations or outpatient appointments in the 180 days after randomization. The functional outcome was assessed by the mRS at 90 days post-discharge. mRS 0-2 was considered as favorable clinical outcome.). 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 NCT07149922, which also lists 5 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 2 Sep 2025.