Comparison of Post-Craniotomy Blood Pressure Targets

Conditions

• Craniotomy Tumor Removal Surgery
• Intracranial Hemorrhage, Hypertensive

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Target SBP <160mmHg — OTHER
  For subjects assigned to the SBP \<160 mmHg group, an SBP target order will be placed to guide the neuro-intensive care team to treat the patient with antihypertensive medications as needed to achieve an SBP \<160 mmHg. Selection of the antihypertensive medication and administration route is at the discretion of the treating team. Patients will undergo regular and frequent blood pressure measurements using the arterial line placed during surgery, or through a non-invasive blood pressure measurement method if no arterial line is present.
• Target SBP <140 mmHg — OTHER
  For subjects assigned to the SBP \<140 mmHg group, an SBP target order will be placed to guide the neuro-intensive care team to treat the patient with antihypertensive medications as needed to achieve an SBP \<140 mmHg. Selection of the antihypertensive medication and administration route is at the discretion of the treating team. Patients will undergo regular and frequent blood pressure measurements using the arterial line placed during surgery, or through a non-invasive blood pressure measurement method if no arterial line is present.

Study Details

The goal of this pragmatic clinical trial is to learn if a more intensive or more liberal blood pressure target after surgery is more effective in improving patient outcomes for adults undergoing craniotomy for removal of a brain tumor. There is little evidence to help doctors decide the best post-operative blood pressure target for their patients. The main question this study aims to answer is if patients with a post-operative systolic blood pressure target of \<160 mmHg will have a shorter hospital length of stay than those with a blood pressure target of \<140 mmHg, without increasing the rate of post-operative bleeding in the brain.

Key Dates

Start date

Apr 15, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Comparator Arm 1: SBP target <160 mmHg
  The neuro-intensive care team will monitor the patient's SBP and treat with antihypertensive medications to achieve an SBP\<160mHg. Selection of the appropriate oral or IV medication is at the discretion of the neuro-ICU team; most frequently used agents clinically include nicardipine, labetalol, and hydralazine. Selection of the appropriate agent is based on other clinical elements including severity of hypertension, heart rate, patients' home medication regimens, and any medication interactions or allergies. The blood pressure goal will be continued throughout the hospitalization. The arterial line will be removed at the discretion of the neurosurgery team, typically on the morning of the first day after surgery.
• Active Comparator: Comparator Arm 2: SBP Target <140 mmHg
  The neuro-intensive care team will monitor the patient's SBP and treat with antihypertensive medications to achieve an SBP\<140mHg. Selection of the appropriate oral or IV medication is at the discretion of the neuro-ICU team, as described above for Comparator Arm 1. The blood pressure goal will be maintained until the neurosurgery team chooses to 'liberalize' the blood pressure goal to higher SBP levels. The arterial line will be removed when the blood pressure goal is liberalized, typically on the morning of the first day after surgery.

Primary Outcome Measure

Hospital length of stay [ Time Frame: From enrollment to first hospital discharge or 90 days, whichever is sooner ]

Locations (1)

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