Evidence map›Paper›PMID 36045358›Full record

Trial reportBMC musculoskeletal disorders2022

Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery.

A Merchán-Galvis, M Posso, E Canovas, M Jordán, X Aguilera, M J Martinez-Zapata

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02150720 (Prevention of Postoperative Bleeding in Femoral Fractures), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 32% 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.

NCT02150720 phase3completednot on this map

Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue

TypeinterventionalSponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauRan2013 to 2016Enrolled161ConditionsHip Fracture, Blood LossArmsTranexamic Acid, Fibrin glue, Electrocauterization
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. 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

6 authors at 4 institutions in 2 countries.

A Merchán-GalvisIberoamerican Cochrane Centre-Public Health and Clinical Epidemiology, IIBSant Pau, Barcelona, Spain.ORCID http://orcid.org/0000-0003-2375-5513
M PossoIberoamerican Cochrane Center - Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.ORCID http://orcid.org/0000-0002-5053-257X
E CanovasIberoamerican Cochrane Centre-IIB Sant Pau, Barcelona, Spain.
M JordánOrthopedic and Traumatology Service, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain.
X AguileraOrthopedic and Traumatology Service, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain.
M J Martinez-ZapataIberoamerican Cochrane Centre-Public Health and Clinical Epidemiology, IIBSant Pau, Barcelona, Spain. mmartinezz@santpau.cat.ORCID http://orcid.org/0000-0002-5836-1138
Hospital de Sant Pau · ESHospital Del Mar · ESIberoamerican Cochrane Centre · ESUniversity of Cauca · CO

Funding

Fundación Mapfre SA/12/AYU/456Ministerio de Sanidad, Servicios Sociales e Igualdad EC11-341
6 · The paper itself

Abstract

backgroundWe assessed quality of life (QoL) of patients undergoing surgery for proximal femur fracture and performed a cost-effectiveness analysis of haemostatic drugs for reducing postoperative bleeding.

methodsWe analysed data from an open, multicentre, parallel, randomized controlled clinical trial (RCT) that assessed the efficacy and safety of tranexamic acid (TXA group) and fibrin glue (FG group) administered topically prior to surgical closure, compared with usual haemostasis methods (control group). For this study we conducted a cost-effectiveness analysis of these interventions from the Spanish Health System perspective, using a time horizon of 12 months. The cost was reported in $US purchasing power parity (USPPP). We calculated the incremental cost-effectiveness ratio (ICER) per QALY (quality-adjusted life-year).

resultsWe included 134 consecutive patients from February 2013 to March 2015: 42 patients in the TXA group, 46 in the FG group, and 46 in the control group. Before the fracture, EuroQol visual analogue scale (EQ-VAS) health questionnaire score was 68.6. During the 12 months post-surgery, the intragroup EQ-VAS improved, but without reaching pre-fracture values. There were no differences between groups for EQ-VAS and EuroQol 5 dimensions 5 levels (EQ-5D-5L) health questionnaire score, nor in hospital stay costs or medical complication costs. Nevertheless, the cost of one FG treatment was significantly higher (399.1 $USPPP) than the cost of TXA (12.9 $USPPP) or usual haemostasis (0 $USPPP). When comparing the cost-effectiveness of the interventions, FG was ruled out by simple dominance since it was more costly (13,314.7 $USPPP) than TXA (13,295.2 $USPPP) and less effective (utilities of 0.0532 vs. 0.0734, respectively). TXA compared to usual haemostasis had an ICER of 15,289.6 $USPPP per QALY).

conclusionsThere were no significant differences between the intervention groups in terms of postoperative changes in QoL. However, topical TXA was more cost-effective than FG or usual haemostasis.

trial registrationClinicalTrials.gov: NCT02150720. Date of registration 30/05/2014. Retrospectively registered.

Indexed as

Tranexamic AcidCost-Benefit AnalysisFemurFibrin Tissue AdhesiveHumansQuality-Adjusted Life YearsQuality of LifeFibrin Tissue AdhesiveTranexamic AcidClinical trialCost-utilityFibrin glueHip fractureQuality of lifeTranexamic acid

Identifiers

PMID36045358
PMCPMC9429462
OpenAlexW4293724628

What OpenQuestion holds

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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.