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By invitation only Not applicable NCT07093151

Comparison of Post-Craniotomy Blood Pressure Targets

No applicable phase (e.g. observational)
Conditions: Intracranial Hemorrhage, Hypertensive Craniotomy Tumor Removal Surgery

Sponsor: Vanderbilt University Medical Center

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Target SBP
OTHER
Target SBP
OTHER
Locations 1
United States (1)
Vanderbilt University Medical Center
Nashville , Tennessee
Technical details
Status
By invitation only
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.04.2026
Completion date
01.09.2028
Registry ID
NCT07093151
Source
clinicaltrials.gov
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