Treatment for Anticoagulant-induced Bleeding

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval, Quebec, Canada
Anticoagulant-induced Bleeding
Eligibility
18+
All Sexes
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Study Summary

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

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Treatment Effectiveness

Effectiveness Progress

1 of 3

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

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

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Anticoagulant-induced Bleeding by sharing your contact details with the study coordinator.