PRISM Clinical Trials

PRISM clinical research

PRISM research team is involved in phase II-IV clinical trials in pulmonary clinics and inpatient critical care settings. We have ongoing clinical trials in Acute Respiratory Distress Syndrome, Sepsis, Pulmonary Artery Hypertension, COPD, and Pulmonary Fibrosis.

Questions? Please contact our study team at pager #11912 or our PI Akram Khan at pager #15351

CLOVERS (Fluids vs. Vasopressors) (IRB 18184):  Will a liberal or restrictive fluid strategy in patients with SEPTIC SHOCK (Sepsis + hypotension) lead to better patient outcomes or how much fluids should be given to a patient before starting vasopressors? Study will provide placards that can be easily followed to keep people in either the early vasopressor or the early liberal fluids arm. Please page our study team at 11912

FRESH (IRB 17539 PLR before fluid administration) –This study aims to determine if patients with SEPTIC SHOCK (Sepsis + hypotension) will benefit from the use of non-invasive dynamic fluid assessments (Passive Leg Raises). Patients enrolled in the study should have a passive leg raise (PLR) test performed each time before fluid with patient to check for fluid responsiveness (>10% change in Stroke volume index give fluids). Instructions are on the card attached to the machine. Please page study team at 11912 or directly contact Dr. Khan to help you do PLR. Mor information regarding on PLR

VICTAS (IRB 18320) this study aims to determine if SEPTIC patients will benefit from a combination of VITAMIN C, Thiamine and Steroids. Please page our study team at 11912.

BEAT (Beraprost-314d Added-on to Tyvaso®) Multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension.

ADAPT (A Patient Registry of the Real-world Use of Orenitram®) Prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of interest.

OPUS (OPsumit USers Registry) Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

FREEDOM-Ev (Trial of the Early Combination of Oral Treprostinil With Background Oral Monotherapy in Subjects With Pulmonary Arterial Hypertension) International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30 days at randomization for their PAH. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311)

INSPIRE (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil) The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.

CATALYST (Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension) This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.

PRISM completed studies

VIOLET (Vitamin D vs. Placebo Trial IRB 16507): This study aims to find out if a single high dose of VITAMIN D for Vitamin D deficient patients at risk for ARDS (due to Pneumonia, Sepsis, Shock, etc) will reduce morbidity and mortality?

ROSE (Reevaluation Of Systemic Early Neuromuscular Blockade IRB 16807) This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.

Retrospective Chart Review of First-time Opsumit®(Macitentan) Users in the United States (OrPHeUS) The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.

Abituzumab in SSc-ILD. The purpose of this trial is to compare two doses of abituzumab with placebo and determine whether abituzumab is more effective, safer, will be better tolerated and can provoke better immune response than placebo in the treatment of patients with SSc-ILD who already receive constant doses of mycophenolate.