Comparison of Post-Craniotomy Blood Pressure Targets

NCT07093151 | Enrolling By Invitation

• 1 other identifier: 250498
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hemorrhage, Hypertensive; Craniotomy Tumor Removal Surgery

Keywords

Perioperative Care; Post-Craniotomy Emergence Hypertension

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  Length of patient hospital stay in days

  From enrollment to first hospital discharge or 90 days, whichever is sooner

Secondary Outcomes (5)

• ICU length of stay

  From enrollment to transfer out of the ICU or 90 days, whichever is sooner.

• Intracranial hemorrhage (ICH) incidence

  From enrollment to hospital discharge

• Patient-Reported Outcome Measurement Information System-10 (PROMIS10) score

  From enrollment to 90 days following enrollment

• Functional Assessment of Cancer Therapy - Brain (FACT-Br) score

  From enrollment to 90 days following enrollment.

• Composite of adverse end-organ hypoperfusion events related to antihypertensive use

  From enrollment to hospital discharge or 90 days, whichever is sooner.

Study Arms (2)

Comparator Arm 1: SBP target <160 mmHg

ACTIVE COMPARATOR

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.

Other: Target SBP <160mmHg

Comparator Arm 2: SBP Target <140 mmHg

ACTIVE COMPARATOR

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.

Other: Target SBP <140 mmHg

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.

Comparator Arm 1: SBP target <160 mmHg

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.

Comparator Arm 2: SBP Target <140 mmHg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 30, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• Access Criteria: Data will be made accessible to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US (1)