Baxter International Inc. (NYSE: BAX), a global leader in renal innovation, today announced the start of a Phase 3 clinical trial evaluating an investigational drug that combines a citrate anticoagulant and renal replacement solution to determine if and to what extent it lengthens the extracorporeal circuit life in acute kidney injury patients treated with continuous renal replacement therapy (CRRT). Currently, there is no citrate anticoagulant approved for use in CRRT in the United States. The first patient has been enrolled in the clinical trial and has received CRRT. The multi-center, prospective, randomized, controlled clinical trial, which is expected to run through 2017, will include an estimated 160 ICU patients in the United States and Canada. Patients will be randomly assigned to receive either CRRT with regional citrate anticoagulant (Prismocitrate 18) or CRRT with no anticoagulant. Additional details of the study can be found on clinicaltrials.gov. ''One potential obstacle in delivering effective CRRT occurs when blood flow through the circuit is slowed or completely stopped by blood clots,'' said Farah Ali, M.D., medical director for Acute therapies at Baxter. ''Extending the life of the extracorporeal circuit can help patients with acute kidney injury remain on renal replacement therapy as prescribed, while reducing potential complications that can occur when the blood circuit needs to be replaced.'' During CRRT, blood passes through the extracorporeal (outside the body) circuit to help clear waste products in the blood, returning it to a normal state. This cleaned blood is then returned to the body. Clinicians can prescribe an anticoagulant to help reduce the likelihood of circuit clotting. When blood flow through the circuit is interrupted, patients may not receive the prescribed dose of CRRT, which may impact its effectiveness. 1 One retrospective study estimated that nearly one-third of patients did not receive the prescribed dose of CRRT, and that interruptions in CRRT were most commonly due to circuit downtime. 2 If approved, the product will provide a standardized formulation of renal replacement fluid combined with a citrate anticoagulant. Combining two different drug solutions together may make it easier for healthcare providers to administer therapy at the bedside.