ACT Registry

Investigator: Brian Bruckner, MD

Study Coordinator: Deborah Barr

Status: Enrolling

ClinicalTrials.gov Number: NCT02145858

Phone: 713.441.3916

IRB Number: Pro00011886

Description

This study is evaluating the effectiveness of PleuraFlow System Active Clearance Technology (ACT) in the management of blood evacuation. The Pleuraflow System ACT is a guided wire with a distal loop that rests at the end of a chest tube. The system uses the loop to morcellate and scoop back clots towards the drainage canister. The system is driven by a proprietary magnetic drive to maintain a sterile environment within the tube. This study will measure the incidence of complication and post-surgical interventions consistent with retained blood after adult cardiac surgery. The prospective multicenter observational registry with a retrospective historical control arm. The controls are consists of a cohort of matched cardiac surgery patients and center with data entered over the preceding 12 to 24-month period. The registry has two tracks. The ALL-ACT track is for sites enrolling a consecutive cohort of cardiac surgery patients, or all comers (TRACK A). The VAD-ACT track is for sites enrolling patients undergoing ventricular assist device (VAD) implant or explant (Track B). Our site will be enrolling in Track B - VAD implants or explants. NOTE: Track B (VAD-ACT track) will be the active tack registry used here at Houston Methodist.
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