Recruiting

OACs

Sponsor:

Hospital Quality Foundation

Code:

NCT02745054

Conditions

Blood Coagulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mgt of bleeding concerns/complications of oral anticoagulants

Study Details

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

Study ID

NCT02745054

Start date

Aug, 2016

Status verified date

May, 2018

Completion date

Oct, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
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:

Patients who meet any of the following criteria are not eligible for inclusion in this registry study:

  • 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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • DESCRIPTIVE: timing endpoints: hours after presentation before any observed intervention [ Time Frame: index hospitalization, generally less than or equal to (LTE) 7 days ]

Central Contacts and Locations

Central contacts

Charles V Pollack, MD

soar.registry@gmail.com

Alex Frost

alex@soar-registry.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Washington University

Recruiting

Saint Louis, Missouri, United States, 63110

Kings County Hospital

Recruiting

Brooklyn, New York, United States, 11203

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44913

Genesis HealthCare

Recruiting

Zanesville, Ohio, United States, 43701

Reading Hospital

Recruiting

West Reading, Pennsylvania, United States, 19611

More Information

Sponsor

Hospital Quality Foundation

Last update posted

May 22, 2018

Last verified

May, 2018

Keywords

  • oral anticoagulants
  • bleeding
  • anticoagulation reversal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Hospital Quality Foundation on 2018-05-22.