Objectives and Design of BLEEDS: A Cohort Study to Identify New Risk Factors and Predictors for Major Bleeding During Treatment with Vitamin K Antagonists

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2016 Dec 10

PMID 27935941

Citations 12

Authors

Nienke van Rein

Willem M Lijfering

Mettine H A Bos

Martien H Herruer

Helga W Vermaas

Felix J M van der Meer

Pieter H Reitsma

Affiliations

Soon will be listed here.

Abstract

Background: Risk scores for patients who are at high risk for major bleeding complications during treatment with vitamin K antagonists (VKAs) do not perform that well. BLEEDS was initiated to search for new biomarkers that predict bleeding in these patients.

Objectives: To describe the outline and objectives of BLEEDS and to examine whether the study population is generalizable to other VKA treated populations.

Methods: A cohort was created consisting of all patients starting VKA treatment at three Dutch anticoagulation clinics between January-2012 and July-2014. We stored leftover plasma and DNA following analysis of the INR.

Results: Of 16,706 eligible patients, 16,570 (99%) were included in BLEEDS and plasma was stored from 13,779 patients (83%). Patients had a mean age of 70 years (SD 14), 8713 were male (53%). The most common VKA indications were atrial fibrillation (10,876 patients, 66%) and venous thrombosis (3920 patients, 24%). 326 Major bleeds occurred during 17,613 years of follow-up (incidence rate 1.85/100 person years, 95%CI 1.66-2.06). The risk for major bleeding was highest in the initial three months of VKA treatment and increased when the international normalized ratio increased. These results and characteristics are in concordance with results from other VKA treated populations.

Conclusion: BLEEDS is generalizable to other VKA treated populations and will permit innovative and unbiased research of biomarkers that may predict major bleeding during VKA treatment.

Citing Articles

Effect of PCC on Thrombin Generation among Patients on Factor Xa Inhibitors with Major Bleeding or Needing Urgent Surgery (GAUGE): Design and Rationale.

Shaw J, Unachukwu U, Cyr J, Siegal D, Castellucci L, Van Dreden P TH Open. 2023; 7(3):e229-e240.

PMID: 37497426 PMC: 10368490. DOI: 10.1055/s-0043-1771300.

Selective Serotonin Reuptake Inhibitor Use and Risk of Major Bleeding during Treatment with Vitamin K Antagonists: Results of A Cohort Study.

Bakker S, Burggraaf J, Kruip M, van der Meer F, Lijfering W, van Rein N Thromb Haemost. 2022; 123(2):245-254.

PMID: 36208621 PMC: 9904966. DOI: 10.1055/a-1957-6305.

Association of VKORC1 polymorphisms and major bleedings in patients who are treated with vitamin K antagonists.

van Heteren D, Lijfering W, van der Meer F, Reitsma P, Swen J, Bos M J Intern Med. 2022; 293(1):124-127.

PMID: 36125842 PMC: 10087804. DOI: 10.1111/joim.13569.

The Immediate Effect of COVID-19 Vaccination on Anticoagulation Control in Patients Using Vitamin K Antagonists.

Visser C, Biedermann J, Nierman M, van der Meer F, Gulpen A, Moors Y Thromb Haemost. 2022; 122(3):377-385.

PMID: 35245945 PMC: 8899332. DOI: 10.1055/s-0042-1742628.

Major bleeding during oral anticoagulant therapy associated with factor V activation by factor Xa.

Maag A, van Rein N, Schuijt T, Kopatz W, Kruijswijk D, Thomassen S J Thromb Haemost. 2021; 20(2):328-338.

PMID: 34773381 PMC: 9299225. DOI: 10.1111/jth.15589.

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