Blood Pressure Targets for Brain Tumor Surgery
(COMPETE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best way to manage blood pressure in adults who have recently undergone surgery to remove a brain tumor. Researchers compare two blood pressure targets to determine which one aids faster recovery and reduces hospital stay, while ensuring it does not increase the risk of brain bleeding. Participants will have their blood pressure managed either below 160 mmHg or below 140 mmHg after surgery. Suitable candidates for this trial have recently had a craniotomy to remove a tumor. As an unphased trial, this study allows participants to contribute to important research that could enhance recovery outcomes for future patients.
What prior data suggests that these blood pressure management protocols are safe for brain tumor surgery patients?
Research has shown that maintaining the systolic blood pressure below 160 mmHg after brain tumor surgery is safe. One study found that this level does not increase the risk of post-surgical brain bleeding. Many hospitals aim for even lower levels, under 140 mmHg, in similar surgeries. Both methods are widely accepted and safe for patients. The choice between these blood pressure targets often depends on each patient's needs and response to treatment.12345
Why are researchers excited about this trial?
Most treatments for managing blood pressure during brain tumor surgery focus on stabilizing the patient without specific targets. However, researchers are excited about this trial because it explores two specific systolic blood pressure (SBP) targets: one below 160 mmHg and another below 140 mmHg. By investigating these precise SBP targets, researchers hope to determine the optimal blood pressure management strategy that minimizes surgical risks and improves patient outcomes. This approach is distinctive because it could lead to more tailored and effective blood pressure management during critical neurosurgical procedures.
What evidence suggests that this trial's blood pressure management strategies could be effective for brain tumor surgery patients?
Research has shown that controlling blood pressure after brain tumor surgery is crucial. High blood pressure can increase the risk of intracranial hemorrhage. This trial assigns participants to one of two treatment arms for blood pressure management. In Comparator Arm 1, the target systolic blood pressure (SBP) is less than 160 mmHg. In Comparator Arm 2, the target SBP is less than 140 mmHg. Previous studies have found that maintaining blood pressure below 140 mmHg after surgery can reduce the risk of complications like brain swelling and seizures. Managing blood pressure carefully has also been linked to better recovery and independence in patients with certain conditions. These findings suggest that controlling blood pressure after surgery could lead to better outcomes for patients.24678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are monitored and treated with antihypertensive medications to achieve target SBP levels post-craniotomy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including PROMIS10 and FACT-Br assessments
What Are the Treatments Tested in This Trial?
Interventions
- Blood Pressure Management
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Citations
The role of postoperative blood pressure management in early ...
Elevated blood pressure during and after surgery can increase the risk of postoperative hemorrhage, potentially leading to detrimental consequences for the ...
Association between hypertension requiring medication ...
Thirty-day outcomes after craniotomy for primary malignant brain tumors: a national surgical quality improvement program analysis. Neurosurgery.
Comparison of Post-Craniotomy Blood Pressure Targets
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 ...
Impact of Hypertension on the Outcomes of Patients With High ...
Patients with HTN appear to be at a higher risk of all-cause mortality, cerebral edema, seizures, and emergency endotracheal intubation, ...
5.
discovery.researcher.life
discovery.researcher.life/article/association-of-preoperative-blood-pressure-with-30-day-mortality-in-patients-undergoing-craniotomy-for-brain-tumor-excision-a-retrospective-database-analysis/f2876d2ae7623209b394cd07fb8272e6Association of Preoperative Blood Pressure With 30-Day ...
The association between preoperative blood pressure and 30-day postoperative mortality in patients undergoing craniotomy for brain tumors ...
Evaluation of the Safety of Liberalized Systolic Blood ...
Liberalization of SBP goals to <160 mm Hg appears safe in the immediate postoperative period after craniotomy for tumor resection without an increased POH risk.
Postoperative Blood Pressure Goals After Craniotomy for ...
Most programs kept a goal SBP of <140 mm Hg (41%-43% depending on the tumor type), followed by SBP <160 mm Hg (36%-39%).
The safety of post-operative elevation of mean arterial ...
MAP therapy in post-operative brain tumor patients appears to be a safe strategy. No attempts have been made in this study to suggest improvement in patient ...
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