Positive clinical trial results for PleuraFlow for the reduction of hospital complications after heart surgery


ClearFlow has revealed positive results from its PROACT (Prevention of retained blood outcomes using active clearance technology) study, which is evaluating its PleuraFlow active clearance technology system to prevent retained blood complications after heart surgery. A company press release reports that the PleuraFlow System enables caregivers to actively keep chest drainage tubes clear of clot in the early hours after heart surgery.

The PRO-ACT trial studied the efficacy of a protocol for actively clearing chest tubes of clotted blood to prevent retained blood complications. The primary outcome of the study was a reduction of interventions for retained blood complications after heart surgery and prior to discharge. The study results were presented at the Cardiovascular- Thoracic (CVT) Critical Care 2014 annual meeting, organised by the Foundation for the Advancement of CardioThoracic Surgical Care (FACTS-Care) in Washington, DC, USA.

The PRO-ACT results were presented by study principal investigator, Theodor Fischlein, of Klinikum Nürnberg Heart Center. The results showed a statistically significant reduction of interventions for retained blood complications by 42% in the treatment group. In addition, the trial revealed a statistically significant reduction of postoperative atrial fibrillation (POAF). Patients treated with the PleuraFlow system also had a statistically significant reduction in bleeding, suggesting that the active clearance technology may help reduce the amount of bleeding after heart surgery.

“We are very pleased to have completed the first trial of its kind in this field that shows an immediate and significant reduction in the need for interventions for retained blood complications, as well as other common complications in patients recovering from heart surgery,” comments Fischlein. “We are always striving for ways to improve outcomes and this appears to be a promising technology that may achieve that goal.”

The company is currently raising capital for further clinical expansion to serve heart surgery patients worldwide, as well as to build its pipeline of products for other surgical fields. The PleuraFlow System with active clearance technology is approved for use in the USA, Europe, Australia, Brazil, and Canada.