Studies, Grants, Projects, Publications
We have a proven track record of completing high-impact studies that have changed clinical practice.
Current projects:
Repeated Ketamine Infusions for Treatment-Resistant Bipolar Depression: A Randomized, Midazolam-Controlled Phase II Clinical Trial (Ket-BD) - A two-site, phase II, double-blinded, midazolam-controlled, two-week RCT evaluating the efficacy, safety and tolerability of four flexibly-dosed adjunctive ketamine infusions (0.5-0.75mg/kg infused over 40 minutes) for acute treatment of moderate to severe Treatment Resistant Bipolar Depression (TRBD) (type I & II) in 100 patients. The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of four repeated sub-anesthetic doses of IV ketamine in moderate to severe TRBD. Secondary objective: Secondary aims include assessing the safety, tolerability and acceptability of IV ketamine and evaluating its effects on suicidal ideations, quality of life, function and duration of effects.
PI: Dr. Joshua Rosenblat
ClinicTrials.gov Identifier: NCT05004896
Prevention of persistent pain with LidocAine iNfusions in breast cancer surgery (PLAN) Trial Multicentre, parallel-group, blinded, 1:1 randomized controlled trial of 1,150 patients undergoing breast cancer surgery The primary objective of this trial is to quantify the effect of an intraoperative IV lidocaine infusion administered during breast cancer surgery compared to placebo on the prevalence of persistent pain 3-months after surgery.
PI: Dr. James Khan
ClinicalTrials.gov Identifier: NCT04874038
FActor REplacement in Surgery - Four-Factor Prothrombin Complex Concentrate versus Frozen Plasma in Bleeding Adult Cardiac Surgical Patients (“FARES-II” Study) Prospective, multi-center, active-control randomized trial comparing prothrombin complex concentrate with frozen plasma in bleeding adult cardiac surgical patients.Phase III, partially blinded, multicenter, randomized, non-inferiority trial in bleeding adult cardiac surgery patients requiring coagulation factor replenishment. This study will determine if PCC can replace plasma for the management of bleeding after cardiac surgery in patients with coagulopathy. The pilot trial at two sites found the trial procedures to be effective and the intervention safe.
PI: Dr. Keyvan Karkouti
ClinicalTrials.gov Identifier: NCT04114643