Evidence map›Paper›PMID 26448724›Full record

ArticleThrombosis journal2015

Low dose compared to variable dose Warfarin and to Fondaparinux as prophylaxis for thromboembolism after elective hip or knee replacement surgery; a randomized, prospective study.

Murray M Bern, Diane Hazel, Elizabeth Deeran, John R Richmond, Daniel M Ward, Damon J Spitz, David A Mattingly, James V Bono, Ronna H Berezin, Laura Hou and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Thrombosis journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00767559 (Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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.

NCT00767559 naunknown statusnot on this map

Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities

TypeinterventionalSponsorThe New England Baptist HospitalRan2008 to 2012Enrolled330ConditionsPulmonary EmbolismArmswarfarin, Fondaparinux:
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pentasaccharides for the prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2016
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
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

12 authors at 2 institutions in 1 country.

Murray M BernDepartments of Medicine, New England Baptist Hospital, Boston, MA USA ; Research, New England Baptist Hospital, Boston, MA USA ; Harvard Medical School, Boston, MA USA ; University of New Mexico Cancer Center, 1201 Camino de Salud, Albuquerque, NM 87131 USA.
Diane HazelResearch, New England Baptist Hospital, Boston, MA USA.
Elizabeth DeeranResearch, New England Baptist Hospital, Boston, MA USA.
John R RichmondOrthopedic Surgery, New England Baptist Hospital, Boston, MA USA ; Tufts University School of Medicine, Boston, MA USA.
Daniel M WardOrthopedic Surgery, New England Baptist Hospital, Boston, MA USA ; Tufts University School of Medicine, Boston, MA USA.
Damon J SpitzDiagnostic Radiology, New England Baptist Hospital, Boston, MA USA ; Tufts University School of Medicine, Boston, MA USA.
David A MattinglyOrthopedic Surgery, New England Baptist Hospital, Boston, MA USA ; Tufts University School of Medicine, Boston, MA USA.
James V BonoOrthopedic Surgery, New England Baptist Hospital, Boston, MA USA ; Tufts University School of Medicine, Boston, MA USA.
Ronna H BerezinResearch, New England Baptist Hospital, Boston, MA USA.
Laura HouResearch, New England Baptist Hospital, Boston, MA USA.
Gerald B MileyDepartments of Medicine, New England Baptist Hospital, Boston, MA USA ; Harvard Medical School, Boston, MA USA.
Benjamin E BierbaumOrthopedic Surgery, New England Baptist Hospital, Boston, MA USA ; Tufts University School of Medicine, Boston, MA USA.
New England Baptist Hospital · USHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDeep vein thrombosis (DVT) and pulmonary emboli (PE), known together as venous thromboembolic (VTE) disease remain major complications following elective hip and knee surgery. This study compares three chemoprophylactic regimens for VTE following elective primary unilateral hip or knee replacement, one of which was designed to minimize risk of post-operative bleeding.

methodsPatients were randomized and stratified for hip vs. knee to receive A: variable dose warfarin (first dose on the night preceding surgery with subsequent target INR 2.0-2.5), B: 2.5 mg fondaparinux daily starting 6-18 h postoperatively, or C: fixed 1.0 mg dose warfarin daily starting 7 days preoperatively. All treatments continued until bilateral leg venous ultrasound day 28 ± 2 or earlier upon a VTE event. The study examined primary endpoints including leg DVT, PE or death due to VTE and secondary endpoints including effects on D-dimer, estimated blood loss (EBL) at surgery and hemorrhagic complications.

resultsThree hundred fifty-five patients were randomized. None was lost to follow-up. Taking 1.0 mg warfarin for seven days preoperatively did not prolong the prothrombin time (PT). Two patients in Arm C had asymptomatic distal DVT. One major bleed occurred in Arm B and one in Arm C (ischemic colitis). Elevated d-dimer did not predict delayed VTE for one year.

conclusionsFixed low dose warfarin started preoperatively is equivalent to two other standards of care under study (95 % CI: -0.0428, 0.0067 for both) as VTE prophylaxis for the patients having elective major joint replacement surgery.

trial registrationClinicalTrials.gov identifier # NCT00767559 FDA IND: 103,716.

Indexed as

ArthroplastyDeep vein thrombosisFondaparinuxHip replacementKnee replacementProphylaxisPulmonary embolusThrombophlebitisWarfarin

Identifiers

PMID26448724
PMCPMC4596510
OpenAlexW1860534956

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.