Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (NCT01722786) | Clinical Trial Compass
CompletedNot Applicable
Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists
Germany272 participantsStarted 2014-04
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
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Patient Eligibility
1. 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 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)
AND
2. with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran)
AND
3. provides informed consent after the acute event