Evidence map›Paper›PMID 36514077›Full record

ArticleBMC musculoskeletal disorders2022

Pneumatic tourniquet versus no tourniquet in transfemoral amputation - a study protocol for a randomized controlled trial.

Anna Trier Heiberg Brix, Tine Nymark, Hagen Schmal, Martin Lindberg-Larsen

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article 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 NCT05550623 (Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation - A Randomized Controlled Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 57% 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.

NCT05550623 naactive not recruitingnot on this map

Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation - A Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Southern DenmarkRan2022 to 2026Enrolled124ConditionsAmputation, Blood LossArmsTourniquet
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Trial
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

4 authors at 3 institutions in 2 countries.

Anna Trier Heiberg BrixDepartment of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark. Anna.trier.heiberg.brix@rsyd.dk.
Tine NymarkDepartment of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.
Hagen SchmalDepartment of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.
Martin Lindberg-LarsenDepartment of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.
Odense University Hospital · DKUniversity Medical Center Freiburg · DEUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLower extremity amputation patients represent a frail group with extensive comorbidity. Transfemoral amputation is a high-risk procedure with 37-50% risk of mortality in the first year. Substantial blood loss during surgery increases the risk of anemic complications and death for these already weakened patients. The use of tourniquet during surgery may reduce blood loss, the need for blood transfusions, the related complications as well as the length of the surgery. However the use of tourniquet may be related to impaired wound healing and hence the use should be investigated in a randomized controlled trial. The primary aim of this study is to investigate the total blood loss and secondary to investigate differences in complications after transfemoral amputation between patients operated with or without tourniquet.

methodsThe total blood loss is calculated using Nadlers approach. Based on data from a pilot series, the sample size was calculated to 124, allocated 1:1 in two groups of 62 participants to ensure detection of at least 200 mL difference in the total blood loss. The primary outcome is the total blood loss. Secondary outcomes are blood transfusions, duration of surgery, length of hospital stay and risk of complications within 90 days (re-admissions, re-operations and mortality). Explorative outcomes are 1 year mortality and re-operation risk. Further explorative outcomes are postoperative quality of life (questionnaire EQ-5D-5L) and evaluation of number of prosthesis users including evaluation of prosthesis-specific function measured 3, 6, and 12 months postoperatively. DISCUSSION: The possibility to enhance patient safety is highly relevant and this trial will provide data for evidence based recommendations of best practice in amputation surgery.

trial registrationThe trial is registered on ClinicalTrials.gov with ID: NCT05550623. Initial release: 13/09 2022.

Indexed as

Quality of LifeTourniquetsAmputation, SurgicalBlood Loss, SurgicalBlood TransfusionHemorrhageHumansLength of StayRandomized Controlled Trials as TopicBlood lossMajor amputationTourniquet

Identifiers

PMID36514077
PMCPMC9746170
OpenAlexW4311822215

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.