Comparison of Post-Craniotomy Blood Pressure Targets

Official title

COMparison of Postcraniotomy Blood pressurE Target Effectiveness (COMPETE)

Overview

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.

Interventions

• Other 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 measurem
• 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 measurem

Primary outcome measures

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

Secondary outcome measures (5)

• ICU length of stay [Time frame: From enrollment to transfer out of the ICU or 90 days, whichever is sooner.]
• Intracranial hemorrhage (ICH) incidence [Time frame: From enrollment to hospital discharge]
• Patient-Reported Outcome Measurement Information System-10 (PROMIS10) score [Time frame: From enrollment to 90 days following enrollment]
• Functional Assessment of Cancer Therapy - Brain (FACT-Br) score [Time frame: From enrollment to 90 days following enrollment.]
• Composite of adverse end-organ hypoperfusion events related to antihypertensive use [Time frame: From enrollment to hospital discharge or 90 days, whichever is sooner.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT07093151 · 250498

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗