Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants (RADOA)
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, when they receive intervention with a reversal agent (e.g. PCC, aPCC; rVIIa and/or hemodialysis (for removal of dabigatran)).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Primary Outcome [ Time Frame: open ] [ Designated as safety issue: Yes ]
- Stop of bleeding
- Fatality rate caused by non-stop bleeding
- In case of urgent operation satisfaction of surgeon during and after surgery concerning bleeding using a standardized questionnaire
- Secondary Outcome [ Time Frame: open ] [ Designated as safety issue: Yes ]
- use versus no use of reversal agents - difference in outcome?
- definition of supportive measures being effective in stopping bleeding
- effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding
Biospecimen Retention: Samples Without DNA
If possible, left-over from plasma samples ("retention sample") should be used to perform further analyses as drug concentrations. Retention samples of very low volume would suffice for HPLC (information on collection method needed) to assess plasma concentrations of anticoagulants in these patients.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Group 1: 130 patients treated with DOA
Group 2: 130 treated with VKA
The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa 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.
Study Registry Design Prospective, Observational, Non-interventional Open-label Multicenter and International
- Non-interventional: TBC as specific analyses are planned on retention blood samples which are taken anyhow during patient management
- Prospective: inclusion into the registry will be done when the acute emergency situation has passed
- Observational: Treatment decision will be at the discretion of the treating physician based on individual patients situation The decision to enter the patient into the registry will occur after all treatment decisions have been taken.
The Main Registry Objective of this Registry is to:
- Document the clinical course, incidence and outcome of various clinical bleeding events associated with DOA in patients with severe bleeding making intervention necessary or who need urgent intervention/surgery that cannot wait AND
- Evaluate the effectiveness of their responses to its intervention treatment including: a. reversal agent; b. haemodialysis; c. waiting;
|Contact: Edelgard Lindhoff-Last, MDfirstname.lastname@example.org|