Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (… (NCT03537521) | Clinical Trial Compass
WithdrawnNot Applicable
Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots
Stopped: due to corona pandemic crisis
0Started 2020-04
Plain-language 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
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
In hospital mortality up to 30 days after admission