Intracranial Hemorrhage, HypertensiveCOMPETENCT07093151
Comparison of Post-Craniotomy Blood Pressure Targets
A study testing Target SBP <160mmHg and Target SBP <140 mmHg in people with Intracranial Hemorrhage, Hypertensive and Craniotomy Tumor Removal Surgery, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhage, Hypertensive, Craniotomy Tumor Removal Surgery
- What is being tested?
- Target SBP <160mmHg and Target SBP <140 mmHg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: COMparison of Postcraniotomy Blood pressurE Target Effectiveness (COMPETE)
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.
Read the 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.
- Being tested
- Target SBP <160mmHg, Target SBP <140 mmHg
- Keywords
- Perioperative Care, Post-Craniotomy Emergence Hypertension
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target SBP <160mmHgOther
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.
Target SBP <140 mmHgOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Target SBP <140 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Length of patient hospital stay in days
Measured: From enrollment to first hospital discharge or 90 days, whichever is sooner
Secondary outcomes (5)
ICU length of stay
Length of patient stay in the Neuro Intensive Care Unit after craniotomy
Measured: From enrollment to transfer out of the ICU or 90 days, whichever is sooner.
Intracranial hemorrhage (ICH) incidence
Rate of intracranial hemorrhage requiring return to the operating room
Measured: From enrollment to hospital discharge
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.
Measured: From enrollment to 90 days following enrollment
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.
Measured: From enrollment to 90 days following enrollment.
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.
Measured: From enrollment to hospital discharge or 90 days, whichever is sooner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start15 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Hemorrhage, HypertensiveStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Kelly, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093151
- Sponsor's protocol ID
- 250498
- Acronym
- COMPETE
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMparison of Postcraniotomy Blood pressurE Target Effectiveness (COMPETE)
- ClinicalTrials.gov ID
- NCT07093151
- Acronym / sponsor ID
- COMPETE / 250498
- Keywords
- Perioperative Care, Post-Craniotomy Emergence Hypertension
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator Arm 1: SBP target <160 mmHg | Active comparator | Other: Target SBP <160mmHgThe 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. |
| Comparator Arm 2: SBP Target <140 mmHg | Active comparator | Other: Target SBP <140 mmHgThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target SBP <160mmHgFor 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. | Other | Comparator Arm 1: SBP target <160 mmHg |
| Target SBP <140 mmHgFor 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. | Other | Comparator Arm 2: SBP Target <140 mmHg |
Primary outcome
Hospital length of stay
Time frame: From enrollment to first hospital discharge or 90 days, whichever is sooner
Length of patient hospital stay in days
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target SBP <160mmHg and Target SBP <140 mmHg in people with Intracranial Hemorrhage, Hypertensive and Craniotomy Tumor Removal Surgery, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: From enrollment to first hospital discharge or 90 days, whichever is sooner). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.