Severe Bleeding, Urgent Surgery
Conditions
Keywords
severe bleeding, dabigatran, rivaroxaban, apixaban, edoxaban, PCC, aPCC, rVIIa, hemodialysis, antidots, idarucizumab, urgent surgery, andexanet alpha
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 patients needing urgent interventions/operations or in 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, Andexanet alpha 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).
Interventions
PROCEDUREUrgent surgery which can not be postponed to the next 24 hrs
The urgent surgical intervention is not part of the registry protocol. The intervention is the acute event that leads to enrollment in the registry. It might be e.g. the surgical treatment of a trauma, fall, acute abdomen, appendicitis or anything else.
Sponsors
Cardioangiologisches Centrum Bethanien
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Group 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 Group 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) * with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran) * provides informed consent after the acute event
Exclusion criteria
for Group a and b: * Conscious patient by him-/ herself or his/ her available legal representative does not agree with inclusion in the registry * Age \< 18 years * Concomitant participation in an interventional trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In hospital mortality up to 30 days after admission | up to 30 days after hospital admission | Death rate (number of deaths) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatality rate caused by unstoppable bleeding | up to 30 days after hospital admission | Death rate (number of deaths) |
| Use versus no use of reversal agents - difference in outcome? | up to 30 days after hospital admission | documentation of use of reversal agents in eCRF |
| Definition of supportive measures being effective in stopping bleeding | up to 30 days after hospital admission | documentation of supportive measures in eCRF |
| Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding | up to 30 days after hospital admission | time frame until stop of bleeding |
| Stop of bleeding defined according to the treating physicians | up to 30 days after hospital admission | Decission according to the treating physicians |
| Blood loss, number of transfusions necessary | up to 30 days after hospital admission | documentation of supportive measures in eCRF |
| Satisfaction of surgeon during and after surgery concerning bleeding | up to 30 days after hospital admission | Decission according to the treating physicians |
| Use versus no use of reversal agents - difference in blood loss and number of transfusions | up to 30 days after hospital admission | documentation of supportive measures in eCRF |
| Delay in performance of surgery due to anticoagulation | up to 30 days after hospital admission | time Frame documented in eCRF |
| Causality assessment: Relation of SAE to anticoagulant medication | up to 30 days after hospital admission | Decission according to the treating physicians |
Outcome results
None listed