Blood CoagulationSOARNCT02745054
Safety of Oral Anticoagulants Registry
An observational study of Blood Coagulation, run by Hospital Quality Foundation at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation
- What is being tested?
- mgt of bleeding concerns/complications of oral anticoagulants
- Type of treatment
- Pill or oral medicine
- How many people
- 1,500 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2016to Oct 2018
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
Charles V Pollack, MD contact
Alex Frost contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Henry Wang, MD
- Recruiting
Kings County Hospital
Brooklyn, New York, 11203
Richard Sinert, DO
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44913
Sharon Mace, MD
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Richard Nowak, MD
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Craig Coleman, PharmD
- Recruiting
Beaumont Hospital
Royal Oak, Michigan, 48073
Carol Clark, MD
- Recruiting
Washington University
St Louis, Missouri, 63110
Douglas Char, MD
- Recruiting
Reading Hospital
West Reading, Pennsylvania, 19611
Adam Sigal, MD
- Recruiting
Genesis HealthCare
Zanesville, Ohio, 43701
James Neuenschwander, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Blood Coagulation
- Being tested
- mgt of bleeding concerns/complications of oral anticoagulants
- Keywords
- oral anticoagulants, bleeding, anticoagulation reversal
- Medical subject headings
- Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mgt of bleeding concerns/complications of oral anticoagulantsOther
Also called anticoagulation emergency management, anticoagulation emergency reversal
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: index hospitalization, generally less than or equal to (LTE) 7 days
Secondary outcomes (6)
hospital length of stay
to include length of stay (LOS) in ED, hospital, and ICU, as applicable, measured in hours or days per medical record
Measured: index hospitalization only, generally LTE 7 days
disposition after emergency care
location as documented in medical record: discharge home, admit inpatient (non-ICU), admit ICU, admit observation status, deceased
Measured: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: blood products utilization: # units
number of units of packed red blood cells, fresh frozen plasma, and/or platelets, as documented in the medical record
Measured: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: reversal products given (with doses and timing)
as per medical record, the doses and time of administration of any concentrated coagulation factors, prothrombin complex concentrate, idarucizumab, or andexanet alfa
Measured: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: in-hospital complications: incidence, description
to be classified according to surgical/medical risk
Measured: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: costs of treatment
- to include ED and total hospital costs of blood products/components, pharmaceutical products, cost of procedures (diagnostic, interventional)
Measured: index hospitalization only, generally LTE 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hospital Quality Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Daiichi Sankyo, CSL Behring, Janssen Scientific Affairs, LLC, Portola Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Charles V Pollack, MD, Study chair, Hospital Quality Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745054
- Sponsor's protocol ID
- HQF-2016-SOAR-1
- Acronym
- SOAR
- Status last verified
- May 2018
- First submitted
- 4 Apr 2016
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02745054
- Acronym / sponsor ID
- SOAR / HQF-2016-SOAR-1
- Conditions
- Blood Coagulation
- Keywords
- oral anticoagulants, bleeding, anticoagulation reversal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospital Quality FoundationUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Daiichi Sankyo, CSL Behring, Janssen Scientific Affairs, LLC, Portola Pharmaceuticals
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (14 listed)
- Bleeding requiring intervention - patients must be taking an OAC and meet at least one of the following criteria:
- Bleeding Concern - patients must be taking an OAC and who, without overt bleeding, meet at least one of the following criteria:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mgt of bleeding concerns/complications of oral anticoagulantsAlso: anticoagulation emergency management, anticoagulation emergency reversalobservational 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 | – |
Primary outcome
DESCRIPTIVE: timing endpoints: hours after presentation before any observed intervention
Time frame: index hospitalization, generally less than or equal to (LTE) 7 days
* 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
6 secondary outcomes
hospital length of stay
Time frame: index hospitalization only, generally LTE 7 days
disposition after emergency care
Time frame: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: blood products utilization: # units
Time frame: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: reversal products given (with doses and timing)
Time frame: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: in-hospital complications: incidence, description
Time frame: index hospitalization only, generally LTE 7 days
DESCRIPTIVE: costs of treatment
Time frame: index hospitalization only, generally LTE 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: No
Related trials for Blood Coagulation
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles V Pollack, MD contact
Alex Frost contact
Charles V Pollack, MD study chair
Hospital Quality Foundation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulation, run by Hospital Quality Foundation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles V Pollack, MD (soar.registry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.