Evidence map›Paper›PMID 29224638›Full record

Trial reportAmerican heart journal2018

Predictors of perioperative major bleeding in patients who interrupt warfarin for an elective surgery or procedure: Analysis of the BRIDGE trial.

Nathan P Clark, James D Douketis, Vic Hasselblad, Sam Schulman, Andrei L Kindzelski, Thomas L Ortel, BRIDGE Investigators

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American heart journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06844227 (Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06844227 recruitingnot on this mapstarted 2021, after this paper: background citation

Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual), a Simple Perioperative Anticoagulant Management Approach, Replacing a Resource-intensive In-person Doctor-patient Consultation, With a Simple Virtual Care Model That Will Provide a New Standard of Care for Patients on a Direct Oral Anticoagulant or Warfarin and Require Elective Surgery/Procedure.

TypeobservationalSponsorMcMaster UniversityRan2021 to 2026Enrolled1,780ConditionsAtrial Fibrillation (AF)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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  13. Accuracy of HAS-BLED and BleedMAP Scores in Predicting Postoperative Bleeding in Anticoagulated Patients Undergoing non-Cardiac Surgery.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

Nathan P ClarkKaiser Permanente Colorado, Aurora, CO. Electronic address: nathan.clark@Kp.org.
James D DouketisMcMaster University, Hamilton, Ontario, Canada.
Vic HasselbladDuke Clinical Research Institute, Durham, NC.
Sam SchulmanMcMaster University, Hamilton, Ontario, Canada.
Andrei L KindzelskiNational Heart, Lung, and Blood Institute, National Institutes of Health, Rockville, MD.
Thomas L OrtelDuke University Medical Center, Durham, NC.
BRIDGE Investigators
McMaster University · CAClinical Research Institute · USDuke Medical Center · USKaiser Permanente · USNational Institutes of Health · US

Funding

BRIDGE TRIALU01HL087229 · NHLBI · DUKE UNIVERSITY · PI ORTEL, THOMAS L · 2008 to 2014
$21.2M
BRIDGE TRIALU01HL086755 · NHLBI · DUKE UNIVERSITY · PI HASSELBLAD, VICTOR · 2008 to 2014
$2.8M
NHLBI NIH HHS U01 HL086755NHLBI NIH HHS U01 HL087229
6 · The paper itself

Abstract

backgroundThe use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described.

methodsBRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure. Multiple logistic regression and time-dependent hazard models were used to identify major bleeding predictors.

resultsWe analyzed 1,813 patients of whom 895 received bridging and 918 received placebo. Median patient age was 72.6 years, and 73.3% were male. Forty-one major bleeding events occurred at a median time of 7.0 days (interquartile range, 4.0-18.0 days) postprocedure. Bridge therapy was a baseline predictor of major bleeding (odds ratio [OR]=2.4, 95% CI: 1.2-4.8), as were a history of renal disease (OR=2.9, 95% CI: 1.4-6.0), and high-bleeding risk procedures (vs low-bleeding risk procedures) (OR=2.9, 95% CI: 1.4-5.9). Perioperative aspirin use (OR=3.6, 95% CI: 1.1-11.9) and postprocedure international normalized ratio >3.0 (OR=2.1, 95% CI: 1.5-3.1) were time-dependent predictors of major bleeding. Major bleeding was most common in the first 10 days compared with 11-37 days postprocedure (OR=3.5, 95% CI: 1.8-6.9).

conclusionsIn addition to bridge therapy, perioperative aspirin use, postprocedure international normalized ratio >3.0, a history of renal failure, and having a high-bleeding risk procedure increase the risk of major bleeding around the time of an elective surgery/procedure requiring warfarin interruption.

Indexed as

Withholding TreatmentAgedAnticoagulantsAtrial FibrillationDalteparinDouble-Blind MethodElective Surgical ProceduresFemaleHumansIncidenceInjections, SubcutaneousMaleNorth CarolinaPostoperative HemorrhageStrokeWarfarinAnticoagulantsDalteparinWarfarin

Identifiers

PMID29224638
PMCPMC5730345
OpenAlexW2760662625

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.