Treatment for Anticoagulant-induced Bleeding

Phase-Based Progress Estimates

Effectiveness

Safety

Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval, Quebec, Canada

Anticoagulant-induced Bleeding

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This study is evaluating whether direct oral anticoagulants are safe and effective in the postoperative period of cardiac surgery.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anticoagulant-induced Bleeding

TransAeris

Xarelto (Rivaroxaban)

Cold stored platelets in 100% plasma stored for 10-14 days

Study Objectives

This trial is evaluating whether Treatment will improve 5 primary outcomes in patients with Anticoagulant-induced Bleeding. Measurement will happen over the course of Evaluation at month 3 after hospital discharge for all the postoperative period.

Month 3

Death with anticoagulant treatment

Hemorrhagic events with anticoagulant treatment

Ischemic events with anticoagulant treatment

Month 3

Quality of life with anticoagulant treatment

Statisfaction of the anticoagulant treatment

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Anticoagulant-induced Bleeding

TransAeris

Xarelto (Rivaroxaban)

Cold stored platelets in 100% plasma stored for 10-14 days

Trial Design

2 Treatment Groups

Group VKA

1 of 2

Group DOAC

1 of 2

Active Control

This trial requires 206 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Group VKA

Drug

103 patients. First intake at postoperative day 1 or later when anticoagulation is secondary indicated. Dosage adapted to INR = [2.0-3.0], parenteral (subcoutaneous low-weight molecular or intravenous unfractionated heparin) until INR > or = 2.0. Daily INR during hospital stay, then management by familial doctor. Duration: 3 months

Group DOAC103 patients - One drug among the 4 DOAC according the morbidity of each patient (preoperative DOAC, oral nutrition recovery). First intake at hospital discharge - parenteral (subcoutaneous low-weight molecular or intravenous unfractionated heparin) during hospital stay. Regular daily dosages according the drug, its indication (atrial fibrillation/flutter or biological mitral replacement/repair or biological tricuspid replacement versus venous thromboembolism) and the morbidity of each patient (age, weight, creatinine ou its clearance). Validation by one referent pharmacist. No biological monitoring. Duration: 3 months

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: evaluation at month 3 after hospital discharge for the last month

This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly evaluation at month 3 after hospital discharge for the last month for reporting.

Who is running the study

Principal Investigator

P. V.

Pierre Voisine, Principal Investigator

Laval University

Closest Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval - Quebec, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Anticoagulant-induced Bleeding. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:

People who have atrial fibrillation or flutter, or who have idiopathic venous thromboembolism disease, should be given postoperative oral anticoagulation therapy if they are having surgery to replace or repair a bioprosthetic heart valve show original

Cardiac surgery, with or without cardiopulmonary bypass