Evidence map›Paper›PMID 35751772›Full record

Trial reportSpine deformity2022

Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery.

John C F Clohisy, Lawrence G Lenke, Mostafa H El Dafrawy, Rachel C Wolfe, Elfaridah Frazier, Michael P Kelly

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Spine deformity, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02053363 (Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 38% 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.

NCT02053363 phase2 / phase3completednot on this map

Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery: A Randomized, Blinded, Controlled Trial

TypeinterventionalSponsorWashington University School of MedicineRan2014 to 2020Enrolled64ConditionsAdult Spinal DeformityArmsTranexamic Acid (Cyklokapron)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

6 authors at 5 institutions in 1 country.

John C F ClohisyDepartment of Orthopedic Surgery, Washington University School of Medicine, St. Louis, MO, USA.
Lawrence G LenkeDepartment of Orthopedic Surgery, Columbia University Medical Center, New York, NY, USA.
Mostafa H El DafrawyDepartment of Orthopedic Surgery, University of Chicago, Chicago, IL, USA.
Rachel C WolfePerioperative Services and Surgical Critical Care, Barnes-Jewish Hospital, St. Louis, MO, USA.
Elfaridah FrazierDepartment of Orthopedic Surgery, Washington University School of Medicine, St. Louis, MO, USA.
Michael P KellyRady Children's Hospital, University of California, 3020 Children's Way, San Diego, CA, 92123, USA. mkelly5@rchsd.org.ORCID http://orcid.org/0000-0001-6221-7406
Washington University in St. Louis · USBarnes-Jewish Hospital · USColumbia University Irving Medical Center · USRady Children's Hospital-San Diego · USUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranexamic acid (TXA) is an anti-fibrinolytic effective in reducing blood loss in orthopedic surgery. The appropriate dosing protocol for adult spinal deformity (ASD) surgery is not known. The purpose of this study was to evaluate two TXA protocols [low dose (L): 10 mg/kg bolus, 1 mg/kg/hr infusion; high dose (H): 50 mg/kg, 5 mg/kg/hr] in complex ASD surgery.

methodsInclusion criteria were ASD reconstructions with minimum 10 fusion levels or planned 3-column osteotomy (3CO). Standard demographic and surgical data were collected. Intraoperative estimated blood loss (EBL) was calculated by suction canisters minus irrigation plus estimated blood lost in sponges, estimated to the nearest 50 mL. Serious adverse events (SAE) were defined a priori as: venothromboembolic event (VTE), cardiac arrhythmia, myocardial infarction, renal dysfunction, and seizure. All SAE were recorded. Simple t tests compared EBL between groups. Mean EBL by total blood volume (TBV), transfusion volume, complications related to TXA were secondary outcomes.

resultsSixty-two patients were enrolled and 52 patients completed the study; 25 were randomized to H and 27 to L. Demographic and surgical variables were not different between the two groups. EBL was not different between groups (H: 1596 ± 933 cc, L: 2046 ± 1105 cc, p = 0.12, 95% CI: - 1022 to 122 cc). EBL as a percentage of TBV was lower for the high-dose group (H: 29.5 ± 14.8%, L: 42.5 ± 26.2%, p = 0.03). Intraoperative transfusion volume (H: 961 ± 505 cc, L: 1105 ± 808 cc, p = 0.5) and post-operative transfusion volume (H: 513 ± 305 cc, L: 524 ± 245 cc, p = 0.9) were not different. SAE related to TXA were not different (p = 0.7) and occurred in 2 (8%) H and 3 (11%) L. There was one seizure (H), 2 VTE, and 2 arrhythmias.

conclusionNo differences in EBL, transfusion volume, nor SAE were observed between H and L dose TXA protocols. High dose was associated with decreased TBV loss (13%). Further prospective study, with pharmacologic analysis, is required to determine appropriate TXA dosage in ASD surgeries. LEVEL OF EVIDENCE: Therapeutic Level II.

trial registrationThe study was registered at Clinicaltrials.gov (NCT02053363) February 3, 2014.

Indexed as

Antifibrinolytic AgentsTranexamic AcidAdultBlood Loss, SurgicalHumansProspective StudiesSeizuresVenous ThromboembolismAntifibrinolytic AgentsTranexamic AcidAdult spinal deformityBlood lossBlood transfusionTranexamic acidTXAVenous thrombosis

Identifiers

PMID35751772
OpenAlexW4283449121

What OpenQuestion holds

Textmetadata
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.