Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists

Urgent Surgery Clinical Trial

— RADOA  

Official title:

Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Management of Severe Bleeding and/or Urgent Interventions During Treatment With Direct Oral Anticoagulants or Vitamin K Antagonists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722786
• Other study ID #: RADOA-Registry
• Status: Completed
• Start date: April 2014
• Est. completion date: July 9, 2019

Study information

• Verified date: July 2020
• Source: Cardioangiologisches Centrum Bethanien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need urgent interventions/operations that cannot wait are included in this registry, or during emergency operations.

Description:

The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa, specific antidots in e.g. severe bleeding patients treated with oral anticoagulants.

By collecting case reports from several university hospitals and clinics, different treatment strategies in clinical practice will be observed and evaluated, and may serve as a comprehensive information resource for the safe management with DOA, but also with the long-term anticoagulation based on coumarin derivatives in the near future.

The current objective of this registry is to:

1. Document the clinical course and outcome of various clinical bleeding events associated with DOA or VKA in patients with severe life-threatening bleeding making intervention necessary

2. Document the clinical course and outcome of urgent surgical interventions within 24 hours after admission in patients under DOA or VKA treatment.

3. Characterisation of therapeutic strategies in stopping acute life-threatening bleeding including following agents and methods:

1. blood transfusion,

2. platelet concentrates

3. reversal agents [e.g. vitamin K, prothrombin complex concentrate (PCC), activated PCC (aPCC), activated factor VII (aVII), fibrinogen concentrate, fresh frozen plasma (FFP)]

4. specific antidots, e.g. idarucizumab

5. haemodialysis

6. desmopressin

7. tranexamic acid

8. no specific treatment in respect to the above mentioned treatments (e.g. stop of medication and waiting until anticoagulant effect of DOA is decreased).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: July 9, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Patient Eligibility

1. a) Bleeding patients:

Anticoagulated patients with DOA or VKA with clinically overt major bleeding according to a specified ISTH definition for non-surgical patients:

• Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome

• Bleeding causing a fall in hemoglobin level of 2 g L-1 (1.24 mmol L-1 ) or more leading to transfusion of two or more units of whole blood or red cells.

OR b) Acute surgical need Patients treated with DOA or VKA and who need urgent operation which cannot wait (< 24 h after last intake of drug)

AND

2. with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran)

AND

3. provides informed consent after the acute event

Related Conditions & MeSH terms

• Hemorrhage
• Severe Bleeding
• Urgent Surgery

Locations

Country	Name	City	State
Germany	Cardioangiology Center Bethanien (CCB)	Frankfurt am Main

Sponsors (11)

Lead Sponsor	Collaborator
Cardioangiologisches Centrum Bethanien	Johannes Gutenberg University Mainz, Ruhr University of Bochum, Städtisches Klinikum Dresden-Friedrichstadt, Technische Universität Dresden, University Hospital Dresden, University Hospital Greifswald, University Hospital, Aachen, University Hospital, Frankfurt, University of Schleswig-Holstein, Vivantes Netzwerk für Gesundheit GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lindhoff-Last E, Herrmann E, Lindau S, et al.: Severe hemorrhage associated with oral anticoagulants— a prospective observational study of the clinical course during treatment with vitamin K antagonists or direct oral anticoagulants. Dtsch Arztebl Int 2020; 117: 312-9. DOI: 10.3238/arztebl.2020.0312

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	Primary observation points (for all patients): In hospital mortality up to 30 days after admission; Secondary observation points (group of patients with life threatening bleeding under oral anticoagulation); Stop of bleeding defined according to the treating physicians; Fatality rate caused by unstoppable bleeding; Use versus no use of reversal agents - difference in outcome?; Definition of supportive measures being effective in stopping bleeding; Effectiveness of specific antidots; Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding; Causality assessment: Relation of SAE to anticoagulant medication	open
Secondary	Secondary Outcome	Secondary observation points (group of patients with acute surgery under oral anticoagulation); Blood loss, number of transfusions necessary; Satisfaction of surgeon during and after surgery concerning bleeding; Use versus no use of reversal agents - difference in blood loss and number of transfusions?; Use versus no use of reversal agents - difference in satisfaction of surgeon using a standardized questionnaire; Causality assessment: Relation of SAE to anticoagulant medication; Delay in performance of surgery due to anticoagulation	open