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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01722786
Other study ID # RADOA-Registry
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05926349 - A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure Phase 3
Recruiting NCT04286438 - Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery or Invasive Procedure Phase 3
Withdrawn NCT03537521 - Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots