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NCT Number: NCT07149922

Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 107000, China

Location contact

Bingcheng Zhu

CONTACT

[email protected]

18361561396

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) 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;

Exclusion criteria

  • 1) 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.

Treatment and study plan

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.

Other names: normal target blood pressure management

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.

Other names: elevated target blood pressure

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingcheng Zhu, Doctor

CONTACT

[email protected]

86-18361561396

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Acronym: EPIC-SAH

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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