[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07093151":3,"trial-entities:NCT07093151":97,"trial-summary:NCT07093151":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":47,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":81,"locations":84,"central_contacts":93,"overall_officials":94,"references":95,"see_also_links":96},"NCT07093151","250498","Comparison of Post-Craniotomy Blood Pressure Targets","COMparison of Postcraniotomy Blood pressurE Target Effectiveness (COMPETE)","ENROLLING_BY_INVITATION","2028-09","2026-04","2026-04-21","2026-04-15","Vanderbilt University Medical Center","OTHER",false,"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 \\\u003C160 mmHg will have a shorter hospital length of stay than those with a blood pressure target of \\\u003C140 mmHg, without increasing the rate of post-operative bleeding in the brain.","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\u002For treatment with IV antihypertensives often requires intensive care unit (ICU) level of care. 40% of academic medical programs use a goal of SBP\\\u003C160mmHg as supported by this limited evidence, while 45% of programs use an even more stringent SBP goal of \\\u003C140mmHg.\n\nThis 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 \\\u003C140 mmHg or SBP \\\u003C160 mmHg during this period. We hypothesize that a target SBP \\\u003C160 mmHg will decrease patient hospital length of stay without increasing the risk of ICH.",[19,20],"Intracranial Hemorrhage, Hypertensive","Craniotomy Tumor Removal Surgery",[22,23],"Perioperative Care","Post-Craniotomy Emergence Hypertension","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},500,"ESTIMATED",[32,37],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Target SBP \u003C160mmHg","For subjects assigned to the SBP \\\u003C160 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 \\\u003C160 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.",[36],"Comparator Arm 1: SBP target \u003C160 mmHg",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Target SBP \u003C140 mmHg","For subjects assigned to the SBP \\\u003C140 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 \\\u003C140 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.",[41],"Comparator Arm 2: SBP Target \u003C140 mmHg",[43],{"measure":44,"description":45,"timeFrame":46},"Hospital length of stay","Length of patient hospital stay in days","From enrollment to first hospital discharge or 90 days, whichever is sooner",[48,52,56,60,64],{"measure":49,"description":50,"timeFrame":51},"ICU length of stay","Length of patient stay in the Neuro Intensive Care Unit after craniotomy","From enrollment to transfer out of the ICU or 90 days, whichever is sooner.",{"measure":53,"description":54,"timeFrame":55},"Intracranial hemorrhage (ICH) incidence","Rate of intracranial hemorrhage requiring return to the operating room","From enrollment to hospital discharge",{"measure":57,"description":58,"timeFrame":59},"Patient-Reported Outcome Measurement Information System-10 (PROMIS10) score","PROMIS10 responses collected at routine postoperative neurosurgery clinic follow-up visits. The PROMIS Global 10 uses T-scores to interpret results. T-scores are standardized scores with a mean of 50 and a standard deviation of 10.","From enrollment to 90 days following enrollment",{"measure":61,"description":62,"timeFrame":63},"Functional Assessment of Cancer Therapy - Brain (FACT-Br) score","FACT-Br responses collected at routine postoperative neurosurgery clinic follow-up visits. This scale is measured on a 5 point Likert-type scale, with higher scores indicating better quality of life.","From enrollment to 90 days following enrollment.",{"measure":65,"description":66,"timeFrame":67},"Composite of adverse end-organ hypoperfusion events related to antihypertensive use","Composite measure of inpatient mortality, acute kidney injury, BNP elevation, and myocardial infarction during hospital stay.","From enrollment to hospital discharge or 90 days, whichever is sooner.","ALL","18 Years",null,{"inclusion":72,"exclusion":75,"raw_text":80},[73,74],"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",[76,77,78,79],"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","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* 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\n\nExclusion Criteria:\n\n* Declines to consent\n* 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).\n* Patient is a prisoner\n* Patient is known to be pregnant",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Nashville","Tennessee","37203","United States",{"lat":91,"lon":92},36.16589,-86.78444,[],[],[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Brain Neoplasm",[],{"nct_id":4,"found":15,"summary":70,"prompt_version":70}]