Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage (EPIC-SAH)

Capital Medical University

Status: Not yet enrolling

Conditions: Aneurysmal Subarachnoid Hemorrhage (aSAH); Aneurysmal Subarachnoid Hemorrhage

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07149922

2023ZD0505106 (Other Grant/Funding Number)

KY-2024-267-01

Details and patient eligibility

About

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

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• 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);

  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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups

Normal Target Blood Pressure

Active Comparator group

Description:

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.

Treatment:

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

Elevated Target Blood Pressure

Experimental group

Description:

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.

Treatment:

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