Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage

NCT07149922 | Not Yet Recruiting DMC

• 2 other identifiers: KY-2024-267-012023ZD0505106
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Aneurysmal Subarachnoid Hemorrhage; Aneurysmal Subarachnoid Hemorrhage (aSAH)

Keywords

aneurysmal subarachnoid hemorrhage; delayed cerebral ischemia; blood pressure; prognosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

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.

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.

Other: Blood pressure was regulated within the elevated target management range

Interventions

Blood pressure was regulated within the normal target management range OTHER

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.

Also known as: normal target blood pressure management

Normal Target Blood Pressure

Blood pressure was regulated within the elevated target management range OTHER

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.

Also known as: elevated target blood pressure

Elevated Target Blood Pressure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Aged 18-75 years;
• \) Patients who underwent clipping or endovascular intervention within 72 hours post-ictus;
• \) 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);
• \) Hunt-Hess grade 1-4 at onset;

You may not qualify if:

• \) Presence of untreated intracranial aneurysms with rupture risk;
• \) Moderate-to-severe cerebral vasospasm confirmed by pre-enrollment digital subtraction angiography (DSA), transcranial Doppler (TCD), or computed tomography angiography (CTA);
• \) 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;
• \) Prior cranial neurosurgery for other central nervous system disorders;
• \) Comorbid major systemic diseases or multi-organ dysfunction with life expectancy \<1 year, potentially compromising study implementation or follow-up observations;
• \) Poorly controlled hypertension despite regular antihypertensive medication (e.g., systolic blood pressure \>160 mmHg during pharmacotherapy);
• \) Pre-onset modified Rankin Scale (mRS) score \>2 points, indicating disability from other causes;
• \) Intraoperative major complications including but not limited to massive cerebral hemorrhage, hypovolemic shock, or malignant brain swelling;
• \) Anticipated inability to complete scheduled follow-up assessments within 180 days;
• \) Pregnancy.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Development Center for Medical Science & Technology National Health Commission of the People's Republic of China: collaborator
• Tianjin Medical University General Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 107000, China

Location

Related Publications (5)

• 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.

  PMID: 26266927 BACKGROUND

• Tagami 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.

  PMID: 24865266 BACKGROUND

• Wang 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.

  PMID: 38016131 BACKGROUND

• Shah 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.

  PMID: 37231236 BACKGROUND

• Minhas 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.

  PMID: 35255708 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bingcheng Zhu, Doctor

CONTACT

86-18361561396; zhubingcheng327@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Early Blood Pressure Intervention after Coiling or Clipping for Aneurysmal Subarachnoid Hemorrhage

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)