Blood Coagulation Clinical Trial
Official title:
Safety of Oral Anticoagulants Registry (SOAR): A National, Hospital-Based, Sentinel Surveillance Study of the Clinical and Economic Impact of Bleeding and Bleeding Concerns Due to the Use of Oral Anticoagulants
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, anti-Xa orals, and anti-thrombin (IIa) 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.
Purpose and Rationale:
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 (NOAC) have been approved by the FDA. The
NOACs are associated with generally fewer and less severe bleeding complications, and 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, and patients taking NOACs sometimes require procedures that cannot be delayed, for
which good hemostasis is desirable, and 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; their anticoagulation impact
cannot be readily monitored by simple, quick tests.
In October 2015 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, international normalized ratio
(INR)-driven pathway for the management of warfarin-related bleeds. Many EDs and hospital
pharmacies are now trying to establish similarly standardized, though not evidence-driven,
pathways for NOAC-related bleeding, and eagerly await the availability of additional specific
reversal agents 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.
This registry is proposed as a large, prospective, multicenter study that identifies the
clinical and economic impact of safety concerns around OAC use on evaluation and management
strategies in the ED and on the inpatient units of participating hospitals. The eventual aim
will be to use these data to inform the gradual development of a new, protocolized safety
standard in the management of OACs in the ED.
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