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Research

Photo for STOP-HARM

STOP-HARM

Official Title

The Strategy To Prevent Hemorrhage Associated with anticogulation in Renal disease management

Status

Ongoing

Overview

Patients with severe chronic kidney disease who develop atrial fibrillation are at high risk of stroke. The use of oral anticoagulation in dialysis patients is controversial and warfarin has uncertain efficacy and is associated with a 10‐20% risk of major bleeding each year. New oral anticoagulants are either contra‐indicated or unstudied in this population. The Watchman device may be an ideal therapy in this population, as it is likely to reduce embolic stroke in dialysis patients with atrial fibrillation who cannot take long‐term oral anticoagulants. Among patients currently receiving oral anticoagulants, implantation of the Watchman device would allow discontinuation of oral anticoagulation, thereby reducing long‐term bleeding risk.

Study Design

Prospective Randomized Open Label Blinded Endpoint (PROBE) trial

Primary Endpoint

The primary outcome of STOP HARM will be the occurrence of major bleeding as defined by the ISTH criteria.

Number of Patients

23

Number of Sites

3

Number of Countries

1

Study Period

2016-2018

Principal Investigator

Carlos Morillo

Research Coordinator

Alex Grinvalds

Collaborators

Boston Scientific