Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists
- Conditions
- Urgent SurgerySevere Bleeding
- Registration Number
- NCT01722786
- Lead Sponsor
- Cardioangiologisches Centrum Bethanien
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome open 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)
1. Stop of bleeding defined according to the treating physicians
2. Fatality rate caused by unstoppable bleeding
3. Use versus no use of reversal agents - difference in outcome?
4. Definition of supportive measures being effective in stopping bleeding
5. Effectiveness of specific antidots
6. Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding
7. Causality assessment: Relation of SAE to anticoagulant medication
- Secondary Outcome Measures
Name Time Method Secondary Outcome open Secondary observation points (group of patients with acute surgery under oral anticoagulation)
1. Blood loss, number of transfusions necessary
2. Satisfaction of surgeon during and after surgery concerning bleeding
3. Use versus no use of reversal agents - difference in blood loss and number of transfusions?
4. Use versus no use of reversal agents - difference in satisfaction of surgeon using a standardized questionnaire
5. Causality assessment: Relation of SAE to anticoagulant medication
6. Delay in performance of surgery due to anticoagulation
Trial Locations
- Locations (1)
Cardioangiology Center Bethanien (CCB)
🇩🇪Frankfurt am Main, Germany