Hospital Quality Foundation

HQF announces the launch of a unique observational registry aimed at depicting the acute and in-hospital management of bleeding complications and bleeding concerns in patients taking oral anticoagulants (OACs).  This registry, called “SOAR”—Safety of Oral Anticoagulants Registry—is collaboratively supported by five companies: Boehringer Ingelheim Pharmaceuticals, CSL Behring USA, Daiichi-Sankyo Inc, Janssen Scientific Affairs LLC, and Portola Pharmaceuticals.  In this pilot protocol, thirty hospitals in the United States will collect demographic, diagnostic, treatment, economic, and in-hospital clinical outcomes data on patients whose care is complicated by their use of OACs.

Until recently, warfarin was the only oral anticoagulant (OAC) available in the US, and a substantial infrastructure has developed around its management. Over the past five years, four non-Vitamin-K antagonist oral anticoagulants (‘NOACs’) have been approved by the FDA. The NOACs are associated with generally fewer and less severe bleeding complications, and have shorter half-lives, often making management of bleeding that complicates the use of these agents less problematic than similar episodes associated with warfarin.  Bleeding during NOAC therapy does occur, however, and patients taking NOACs sometimes require procedures that cannot be delayed, for which unimpaired hemostasis is desirable; therefore the NOAC may delay or complicate care. The challenge of this latter issue is compounded by the lack of readily available, rapid- turnaround quantitative assays for measuring the magnitude of anticoagulation effect associated with NOAC use.  From a safety perspective, the large warfarin infrastructure does not translate into useful support for use of the new NOACs.

In October 2015, idarucizumab, the first specific reversal agent for a NOAC was approved, but it is useful only for dabigatran; at present, there is no specific reversal agent for anti-Xa NOACs. Emergency care providers face many concerns and insecurities regarding the safety of warfarin and the NOACs, while working in a highly pressurized care environment, often with limited patient history and little time to consider treatment options.

Because of the unique position of the hospital ED in the US healthcare continuum, it is frequently the initial site of care for patients on OACs who develop bleeding complications. In all clinical settings, there tends to be a standardized, INR-driven pathway for the management of warfarin-related bleeds. Many EDs and hospital pharmacies are now trying to establish similarly standardized pathways for dabigatran-related bleeding.  Protocols for anti-Xa NOAC-treated bleeding issues, however, are not yet evidence-driven, while we eagerly await the availability of a specific reversal agent to use in such patients.

The ED represents the key sentinel surveillance point for assessing the clinical and economic impact of bleeding concerns and complications attributable to OAC therapy. Other bleeding issues that impact the pace and nature of medical and surgical care occur in the inpatient setting, especially the ICU and surgical suite. Taken together, the hospital setting (ED plus inpatient) offers a 360-degree view of the scope, significance, and cost of OAC-related bleeds and bleeding concerns.

The goal of SOAR is to characterize the clinical and economic impact of clinicians’ responses to major bleeding complications and pre-procedural concerns for bleeding risk in patients treated with oral anticoagulants (warfarin, dabigatran, and anti-Xa orals) who present to the ED or in the hospital with acute illness or injury, with the eventual aim of informing the development of improved approaches to the management of OACs in the ED.

If you think your emergency department / hospital would be appropriate for participation in SOAR, please contact us at Participation in SOAR is limited to sites in the United States only.