Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1500 participants
OBSERVATIONAL
2016-08-31
2018-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Anticoagulant Therapy for Venous Thrombosis - SCOR in Thrombosis
NCT00005684
Precision Medicine Platform for Novel Oral Anticoagulants
NCT04056143
OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
NCT06929182
Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants
NCT02185027
Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients
NCT02792335
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mgt of bleeding concerns/complications of oral anticoagulants
observational study of clincians' management of patients taking oral anticoagulants and having acute significant bleeding or requiring management of bleeding risk before an emergent procedure; observation limited to index hospitalization only
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Acute bleeding that is potentially life-threatening at presentation
* Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL
* Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline hemoglobin is available
* Acute symptomatic bleeding in a critical area or organ
* Any intracranial bleeding
* Bleeding for which more than 8 hours of direct patient monitoring is required prior to ED disposition
* Bleeding for which intravenous (IV) Vitamin K, fresh frozen plasma (FFP), any prothrombin complex concentrates (PCC) or activated PCC (aPCC), any specific factor replacement or reversal agent, or a parenteral hemostatic agent such as tranexamic acid is administered
* Bleeding for which packed red blood cells (PRBCs) or platelets are transfused
2. Bleeding Concern - patients must be taking an OAC and who, without overt bleeding, meet at least one of the following criteria:
* Diagnostic or therapeutic surgical procedure for which hemostasis is desirable (e.g., emergency laparotomy) and which, in the opinion of the treating physician, cannot be postponed at least 8 hours
* Diagnostic or therapeutic percutaneous procedure for which hemostasis is desirable (e.g., lumbar puncture) and which, in the opinion of the treating physician, cannot be postponed at least 8 hours
* Overdose (deliberate or accidental) of one or more OAC agents that, in the opinion of the treating physician, requires the administration of Vitamin K, FFP, any PCC or aPCC, any specific factor replacement or specific reversal agent, or a parenteral hemostatic agent such as tranexamic acid, with the desire of immediate reversal of anticoagulation
* Bleeding concern for which, in the opinion of the treating physician, more than 8 hours of direct patient monitoring is required prior to ED disposition
Exclusion Criteria
* Those who have received an investigational reversal agent for an OAC during the index event (data on these patients will be collected as part the pertinent investigational study).If during the course of SOAR enrollment an investigational reversal agent is approved, and that agent is used outside a registration study, that subject is not excluded.
* Those who have received treatment for a bleed or bleeding concern at another facility immediately prior to being transferred to the enrolling facility.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Daiichi Sankyo
INDUSTRY
CSL Behring
INDUSTRY
Janssen Scientific Affairs, LLC
INDUSTRY
Portola Pharmaceuticals
INDUSTRY
Hospital Quality Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles V Pollack, MD
Role: STUDY_CHAIR
Hospital Quality Foundation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Hartford Hospital
Hartford, Connecticut, United States
Henry Ford Hospital
Detroit, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Washington University
St Louis, Missouri, United States
Kings County Hospital
Brooklyn, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Genesis HealthCare
Zanesville, Ohio, United States
Reading Hospital
West Reading, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Henry Wang, MD
Role: primary
Craig Coleman, PharmD
Role: primary
Richard Nowak, MD
Role: primary
Carol Clark, MD
Role: primary
Douglas Char, MD
Role: primary
Richard Sinert, DO
Role: primary
Sharon Mace, MD
Role: primary
James Neuenschwander, MD
Role: primary
Adam Sigal, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HQF-2016-SOAR-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.