No medical condition will be investigated. This study will only investigate DOAC levels during surgery. Patients who use DOACs are patients with venous thrombosis and atrial fibrillation.
Conditions
Interventions
Trade Name: Pradaxa
Product Name: Dabigatran
Product Code: EU/1/08/442/001
Pharmaceutical Form: Capsule, hard
Trade Name: Xarelto
Product Name: Rivaroxaban
Product Code: EU/1/08/472/025
Pharmaceutica
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: 1. Aged 18 years or above. 2. Use of a DOAC that was initiated at least one week before surgery (apixaban, rivaroxaban or dabigatran). 3. Have an elective surgery in the LUMC for which discontinuation of DOAC treatment is required. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study: 1. Be intellectually disabled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure DOAC levels just before surgery of all DOAC patients in the LUMC with elective surgery for which ceasing of DOAC treatment is required.;Secondary Objective: Not applicable;Primary end point(s): DOAC levels measured by liquid chromatography–mass spectrometry (LC-MS) will be the main outcome of the study.;Timepoint(s) of evaluation of this end point: Just before and after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Just before and after surgery: DOAC levels measured by coagulation tests, PT, APTT During surgery: perioperative blood loss Up to 7 days after surgery: blood product received during surgery and other major bleeding;Secondary end point(s): Secondary outcomes are: - DOAC levels measured by specific coagulation tests for DOACs (diluted thrombin time or anti-Xa levels depending on the DOAC used) - Prothrombin time (PT) - Activated Partial Thromboplastin Time (APTT) - Perioperative blood loss - Blood product received during surgery and other major bleeding during up to 7 days after surgery | — |
Countries
Netherlands
Contacts
Public ContactStudy coordinator
Leiden University Medical Center
Outcome results
None listed