Safety of Oral Anticoagulants Registry

NCT02745054 | Unknown

• 1 other identifier: HQF-2016-SOAR-1
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Blood Coagulation

Keywords

oral anticoagulants; bleeding; anticoagulation reversal

Outcome Measures

Primary Outcomes (1)

• DESCRIPTIVE: timing endpoints: hours after presentation before any observed intervention

  * to include time to procedure/surgery, time to infusion of one of listed medicines (PCC, aPCC, rfVIIa, idarucizumab, tranexamic acid, andexanet alfa \[once approved\]), type of invasive procedure/surgery, delays in procedure/surgery, relation of interventions/procedures performed to the index event, all determined by review of the medical record * type of invasive procedure/surgery (diagnostic/therapeutic), as documented in the medical record * reason for any delay in procedure, as documented in the medical record * procedure attributable to index event, as documented in the medical record

  index hospitalization, generally less than or equal to (LTE) 7 days

Secondary Outcomes (6)

• hospital length of stay

  index hospitalization only, generally LTE 7 days

• disposition after emergency care

  index hospitalization only, generally LTE 7 days

• DESCRIPTIVE: blood products utilization: # units

  index hospitalization only, generally LTE 7 days

• DESCRIPTIVE: reversal products given (with doses and timing)

  index hospitalization only, generally LTE 7 days

• DESCRIPTIVE: in-hospital complications: incidence, description

  index hospitalization only, generally LTE 7 days

Interventions

mgt of bleeding concerns/complications of oral anticoagulants OTHER

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

Also known as: anticoagulation emergency management, anticoagulation emergency reversal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years and older who present to the ED or hospital with an acute illness or injury and must, in the opinion of the treating clinician, be experiencing an active anticoagulation effect due to the use of an OAC, and have either: 1. Bleeding requiring specific intervention (see below); or 2. Bleeding concern in a non-bleeding patient requiring a specific invasive diagnostic assessment or therapeutic intervention prompting reversal, repletion or decontamination, or a clinically significant delay in intervention due to the use of an OAC (see below).

You may qualify if:

• Bleeding requiring intervention - patients must be taking an OAC and meet at least one of the following 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Quality Foundation: lead
• Boehringer Ingelheim: collaborator
• Daiichi Sankyo: collaborator
• CSL Behring: collaborator
• Janssen Scientific Affairs, LLC: collaborator
• Portola Pharmaceuticals: collaborator

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Kings County Hospital

Brooklyn, New York, 11203, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44913, United States

RECRUITING

Genesis HealthCare

Zanesville, Ohio, 43701, United States

RECRUITING

Reading Hospital

West Reading, Pennsylvania, 19611, United States

RECRUITING

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles V Pollack, MD

  Hospital Quality Foundation

  STUDY CHAIR

Central Study Contacts

Charles V Pollack, MD

CONTACT

soar.registry@gmail.com

Alex Frost

CONTACT

alex@soar-registry.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 20, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)