Comparison of Post-Craniotomy Blood Pressure Targets

NCT ID: NCT07093151

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-03-31

Brief Summary

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.

Detailed Description

Over 160,000 craniotomies, a type of brain surgery, are performed annually in the United States. High blood pressure is believed to increase the risk of post-operative bleeding in the brain, known as intracranial hemorrhage (ICH). This perceived risk has led many doctors to impose post-operative systolic blood pressure (SBP) limits, with aggressive treatment when SBP rises above the target thresholds. The use of intensive SBP goals often requires antihypertensive medication treatment, occasionally including intravenous (IV) drips. These medical therapies could have several adverse effects related to end-organ function. Additionally, close SBP monitoring with an arterial line and/or treatment with IV antihypertensives often requires intensive care unit (ICU) level of care. 40% of academic medical programs use a goal of SBP<160mmHg as supported by this limited evidence, while 45% of programs use an even more stringent SBP goal of <140mmHg.

This study is a single-center, pragmatic, randomized trial comparing the effectiveness of these two standard-of-care post-craniotomy SBP goals in reducing patient hospital length of stay, risk of ICH, and adverse side effects of antihypertensive use. Eligible patients will be randomized to receive an order for a target SBP <140 mmHg or SBP <160 mmHg during this period. We hypothesize that a target SBP <160 mmHg will decrease patient hospital length of stay without increasing the risk of ICH.

Conditions

Intracranial Hemorrhage, Hypertensive; Craniotomy Tumor Removal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Target SBP <160mmHg

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Target SBP <140 mmHg

Intervention Type: 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.

Interventions

Target SBP <160mmHg

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.

Intervention Type: OTHER

Target SBP <140 mmHg

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Undergoes craniotomy for resection of an intradural brain tumor scheduled using any of the following Current Procedural Terminology (CPT) codes: 61304, 61305, 61330, 61333, 61510, 61512, 61516, 61518, 61519, 61520, 61521, 61524, 61526, 61530, 61545, 61580, 61581, 61582, 61583, 61584, 61585, 61586, 61590, 61591, 61592, 61595, 61596, 61597, 61598, 61600, 61601, 61605, 61606, 61607, 61608, 61615, 61616

Exclusion Criteria

• Declines to consent
• Attending decisions based on intraoperative findings (i.e. attending physician does not have equipoise that either blood pressure threshold would be acceptable for the post-operative care of the patient).
• Patient is a prisoner
• Patient is known to be pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Patrick Kelly

Principal Investigator, Assistant Professor of Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Patrick Kelly, MD, MSCI

Role: CONTACT

patrick.kelly@vumc.org

615-322-7417

Kylie Nairon, PhD

Role: CONTACT

kylie.nairon@vumc.org

Other Identifiers

250498

Identifier Type: -

Identifier Source: org_study_id