The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

The University of Chicago

Status: Enrolling

Conditions: Surgery

Treatments: Procedure: Routine Elective Surgery- In patient or out patient elective surgery; Diagnostic Test: Blood test for genetic testing; Other: Drug-genetic Profile

Study type: Interventional

Funder types: Other

Identifiers

NCT03729180

IRB17-1422

Details and patient eligibility

About

The study is enrolling adults who are scheduled for either inpatient or outpatient elective surgical procedures at The University of Chicago.

At pre-operative visits, patients will be consented and a blood sample will be obtained for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk.

Genotyping results will be delivered to participating providers as patient-specific drug-gene clinical decision support summaries using a secured Web portal, the Genomic Prescribing System (GPS).

Participating anesthesiologists and critical care and pain management physicians and associated providers from the Department of Anesthesia and Critical Care at the University of Chicago will be invited to receive results for their participating patients.

There will be an initial 6- month "run-in" period of the study comprised of approximately 100 enrolled adults in which all patients will have pharmacogenomic results made available to providers. The run-in period will allow for process refinement and GPS delivery to be examined and optimized prior to the randomized phase

After the initial run-in period, patients will be randomized to one of two arms - in the pharmacogenomic arm, providers will have access to GPS and pharmacogenomic information, whereas in the control arm, providers will not have access to GPS and patient-specific pharmacogenomic information (current standard of care).

Enrollment: 1,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients who have planned elective surgical procedures at the University of Chicago
• Must be aged 18 years or older

Exclusion criteria

• Patients who have undergone, or are being actively considered for, liver or kidney transplantation
• Patients with known active or prior leukemia.
• Inability to understand and give informed consent to participate.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,900 participants in 3 patient groups

Pain Cohort

Other group

Description:

Patients with a post-operative pain consult will be included in a pain sub-analysis to assess pain scores, pain therapy administration, and rate of opioid-induced adverse events.

Treatment:

Other: Drug-genetic Profile

Diagnostic Test: Blood test for genetic testing

Procedure: Routine Elective Surgery- In patient or out patient elective surgery

Pharmacogenomic (PGx) Arm [Randomization Arm 1]

Experimental group

Description:

All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.

Treatment:

Other: Drug-genetic Profile

Diagnostic Test: Blood test for genetic testing

Procedure: Routine Elective Surgery- In patient or out patient elective surgery

Control Arm [Randomization Arm 2]

Other group

Description:

All patients will undergo preemptive genotyping prior to their surgical procedure. Pharmacogenomic test results will not be made available to providers (standard of care). Genotyping results will be released to study providers (and patients) at the 6-month unblinding timepoint for patients in the control group.

Treatment:

Diagnostic Test: Blood test for genetic testing

Procedure: Routine Elective Surgery- In patient or out patient elective surgery