Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-31 @ 2:52 PM
Study NCT ID:
NCT07093151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Post-Craniotomy Blood Pressure Targets
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
COMparison of Postcraniotomy Blood pressurE Target Effectiveness (COMPETE)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPETE
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: