Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing



Status:Withdrawn
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:October 20, 2018
End Date:May 20, 2020

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In the perioperative realm, studies have demonstrated an association of genotype with
efficacy of medications applicable to the surgical setting. A clinical association exists
between the genotype of various genes and with opioid efficacy and toxicity - specifically
for drugs such as oxycodone, codeine, morphine, fentanyl, and tramadol. More studies are
needed to assess the effects of personalized dosing of analgesics during the perioperative
process for various surgical procedures. The application of Pharmacogenomic testing (PGx) to
perioperative medicine is novel, has much potential for growth and may potentially improve
outcomes. However, successful implementation of a system to evaluate PGx and integrate
results into clinical decision-making is challenging and has not been adequately assessed.
The investigators propose to conduct PGx testing for patients undergoing surgery, evaluate
its clinical utility, and assess outcomes. The investigators hypothesize that PGx testing may
ultimately lead to a decrease in adverse events and improved outcomes in the perioperative
period.

Potential subjects will participate in screening with a minimum of 4 days prior to their
planned surgery. The study involves obtaining mouth swab samples for genetic testing and
employing standardized measures for PGx testing of subjects preoperatively.

Study staff will pre-screen potential subjects scheduled at the preoperative center or on
surgeons' operative schedules. The study team member will ask the treating clinician involved
with the care of a patient for permission to speak to the patient. The physician or a member
of the research staff will describe the study to potentially eligible patients and a study
investigator will obtain consent. After meeting inclusion and exclusion criteria, subjects
who agree to participate in the study will complete study questionnaires and provide a swab
sample for PGx analysis.

Trained members of the research staff will obtain a buccal swab sample from each subject who
has given informed consent to participate in study procedures. The buccal swab will be
packaged and shipped to an outside laboratory for processing and the conduct of the PGx
testing. The results of the PGx testing will be provided in a standardized report and sent
back to the research staff conducting the study. Typically, the turn-around for shipping the
sample and obtaining the results will be 4 days. The results will be available to the
anesthesiologist prior to the patient's surgery.

Prior to the initiation of the scheduled surgery, the anesthesiologist will be asked to
complete a questionnaire about the clinical utility of PGx testing for that subject. In the
perioperative group of subjects for whom clinicians find clinical utility for PGx testing
(experimental group), outcomes will be compared to the remaining subjects (control group) for
whom PGx testing was felt not to have any clinical utility.

After surgery, there will be two assessment periods. Clinical outcomes and the quality of the
subject's recovery from surgery will be assessed postoperatively at 24 hours +/-4 hours after
surgery by directly interviewing each study subject and reviewing the electronic medical
record. Additional assessments of subjects will be conducted by review of the electronic
medical record at 30 days +/- 3 days postoperatively.

Inclusion Criteria:

1. Adults 18 years of age or older at screening.

2. Adults with qualifying insurance coverage.

3. Subjects scheduled to undergo elective surgery with an expected hospitalization 24 hrs
=/- 4 hrs after surgery.

4. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.

5. One or more of the following:

- Subjects prescribed 4 or more medications at time of surgery.

- Any subject prescribed any one of the following medication categories: opioid,
benzodiazepine, antidepressant, antipsychotic, stimulant, mood stabilizer,
NSAIDs, anti-epileptic drugs.

- Any subject prescribed any one of the following medication categories:
antiplatelet therapy, anticoagulant drugs.

6. Able to provide informed consent, adhere to the study protocol, and complete all study
assessments.

Exclusion Criteria:

1. Subjects who do not have insurance coverage for PGx testing.

2. Subjects who are expected to have surgery prior to the ability to obtain the results
of the pharmacogenomic testing (generally it takes 4 days to obtain the results of
testing).

3. Subjects who are not being prescribed 4 or more medications, or who are not receiving
any of the medication categories noted in the inclusion criteria.

4. Planned multiple surgical procedures within the 30-day study follow up period.

5. Clinically significant medical or psychiatric disease that, in the opinion of the
investigator, would make participation in a clinical study inappropriate. This
includes any psychiatric or other disease that would cause the subject to be unable to
comply with the study requirements.

6. Administration of an investigational drug within 30 days prior to providing PGx
testing, or planned administration of an investigational product during the subject's
participation in this study
We found this trial at
2
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Richard Urman, M.D.
Phone: 857-282-1900
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Xiaodong Bao, M.D.
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Boston, MA
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