Evidence map›Paper›PMID 39210304›Full record

Trial reportBMC musculoskeletal disorders2024

Comparison of exsanguination and hemostasis devices for Limb surgery: a multicenter randomized controlled study.

Jianjie Xu, Keqi Zhao, Shaonan Xu, Jianqiao Xu, Binbin Sun, Songlin Tong, Wangxiang Yao, Qing Bi, Zhengming Yang, Weifeng Zhou

Abstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in BMC musculoskeletal disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

10 authors.

Jianjie XuDepartment of Orthopedics, Cixi People Hospital Medical Health Group (Cixi People Hospital), Zhejiang, 315300, China.
Keqi ZhaoDepartment of Orthopedics, Cixi People Hospital Medical Health Group (Cixi People Hospital), Zhejiang, 315300, China.
Shaonan XuDepartment of Orthopedics, Cixi People Hospital Medical Health Group (Cixi People Hospital), Zhejiang, 315300, China.
Jianqiao XuDepartment of Orthopedics, Cixi People Hospital Medical Health Group (Cixi People Hospital), Zhejiang, 315300, China.
Binbin SunDepartment of Orthopedics, Cixi People Hospital Medical Health Group (Cixi People Hospital), Zhejiang, 315300, China.
Songlin TongDepartment of Orthopedics, Cixi People Hospital Medical Health Group (Cixi People Hospital), Zhejiang, 315300, China.
Wangxiang YaoDepartment of Orthopedics, Hangzhou First People's Hospital, Zhejiang University School of Medicine, Zhejiang, 310006, China. Yaowx04@163.com.
Qing BiDepartment of Orthopedics, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Zhejiang, 310014, China. biqing@hmc.edu.cn.
Zhengming YangDepartment of Orthopedics, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Zhejiang, 310009, China. 2200013@zju.edu.cn.
Weifeng ZhouDepartment of Orthopedics, Cixi People Hospital Medical Health Group (Cixi People Hospital), Zhejiang, 315300, China. 13806646055@139.com.

Funding

Cixi City Agriculture and Social Development Science and Technology Program CN2020008the Medical Health Science and Technology Project of Zhejiang Provincial Health Commission 2020KY906Zhejiang Provincial Natural Science Foundation of China LGF20H060002
6 · The paper itself

Abstract

backgroundExcessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage).

methodsThis randomized controlled trial evaluates the exsanguination tourniquet ring's effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators.

resultsThe experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device.

conclusionsThe exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries.

trial registrationComparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.

Indexed as

Blood Loss, SurgicalExsanguinationTourniquetsAdultAgedExtremitiesFemaleHemostasis, SurgicalHumansMaleMiddle AgedProspective StudiesTreatment OutcomeClinical trialsControlled as topicExsanguinationExsanguination tourniquet ringHemostasisSurgicalTourniquets

Identifiers

PMID39210304
PMCPMC11360307

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.