Anticoagulant-induced Bleeding
Conditions
Keywords
direct oral anticoagulant, vitamin K antagonist, cardiac surgery, perioperative care
Brief summary
Postoperative management of oral anticoagulation is a frequent preoccupation in cardiac surgery, concerning about half of patients. Vitamin K antagonists are often recommended but their management is not easy due to the high dose-response patient variability. Pharmacologically more stable, direct oral anticoagulants have similar efficiency in preventing thromboembolic complications while they decrease the risk of bleeding in certain patient populations. The objective of study is to assess the safety and efficacy of direct oral anticoagulants in the postoperative period of cardiac surgical procedures.
Detailed description
This study will be composed by 2 groups of 103 participants, patients undergoing cardiac surgery and needing oral anticoagulation in the early postoperative period. The control group will receive vitamin K antagonist and the study group will receive direct oral anticoagulant. The investigators will call back each participants at 3 months to report the ischemic and bleeding complications during this period and evaluated the quality of life of the oral anticoagulation.
Interventions
DRUGWarfarin
It will be started on postoperative day 1 or later when oral anticoagulation is secondary indicated. Daily dose will be adapted to obtain an international normalized ratio of \[2.0-3.0\]. Other anticoagulants will be not administrated.
DRUGDabigatran
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
DRUGRivaroxaban
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
DRUGApixaban
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
DRUGEdoxaban
It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cardiac surgery, with or without cardiopulmonary bypass * Indication of postoperative oral anticoagulation: preoperative (atrial fibrillation/flutter of idiopathic venous thromboembolism disease), intraoperative (bioprosthetic mitral valve replacement/mitral valve repair or bioprosthetic tricuspid valve repair), postoperative (de novo persistent more than 24 hours or recurrent atrial fibrillation/flutter, venous thromboembolism)
Exclusion criteria
* mechanical valvular prostheses or ventricular assist devices * morbidly obesity (body mass index ≥ 40 kg/m²), prior biliopancreatic diversion or sleeve gastrectomy * perioperative dysphagia needing naso-enteric tube or jejunostomy * antiretroviral of antifungal oral therapy * perioperative recent (less than 2 weeks) stroke * perioperative severe renal failure (clearance of creatinine under 30 mL/min or dialysis) * perioperative severe hepatic failure (elevated alanine aminotransferase more than 3 times the superior limit of normal range or cirrhosis) * perioperative recent (less than 3 months) heparin-induced thrombocytopenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhagic events with anticoagulant treatment | Evaluation at month 3 after hospital discharge for all the postoperative period | The investigators will use the regional computerized medical record of each participants to report all the hemorrhagic event during all the postoperative period, and define them according the Bleeding Academic Research Consortium (BARC) criteria. Hemorrhage-free survival will be studied. |
| Ischemic events with anticoagulant treatment | Evaluation at month 3 after hospital discharge for all the postoperative period | The investigators will use the regional computerized medical record of each patients to report all the ischemic event during all the postoperative period. Ischemia-free survival will be studied. |
| Death with anticoagulant treatment | Evaluation at month 3 after hospital discharge for all the postoperative period | The investigators will use the regional computerized medical record of each patients to report all the ischemic event during all the postoperative period. Global survival will be studied. Ischemic or hemorrhagic death will be precised. |
| Quality of life with anticoagulant treatment | Evaluation at month 3 after hospital discharge for the last month | The investigators will call back all the participants by phone and use the SF-12 questionnaire (score between 12 and 56) to evaluate the quality of life about several dimensions (global, physic, mental, pain, society). |
| Statisfaction of the anticoagulant treatment | Evaluation at month 3 after hospital discharge for the last month | The investigators will call back all the participants by phone and use the anti-clot treatment scale (ACTS) to evaluate the feelings of burdens (score between 12-60) and benefits (score between 3-15) of the anticoagulant treatment |
Outcome results
None listed