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Randomized Controlled Trial
. 2021 Aug 10;64(4):E449-E456.
doi: 10.1503/cjs.014220. Epub 2021 Aug 1.

Topical tranexamic acid in hip fractures: a randomized, placebo-controlled double-blinded study

Darren Costain  1 , Graham Elder  2 , Brian Fraser  2 , Brad Slagel  2 , Adrienne Kelly  2 , Yifun Cheong  2 , Luke Fera  2
Affiliations
Randomized Controlled Trial

Topical tranexamic acid in hip fractures: a randomized, placebo-controlled double-blinded study

Darren Costain et al. Can J Surg. .

Abstract
in English, French

Background: Tranexamic acid (TXA) has been shown to reduce perioperative blood loss in elective orthopedic surgery. The safety of intravenous TXA in nonelective hip fracture surgery is uncertain. The purpose of this study was to evaluate the efficacy and safety of topical TXA in hip fracture surgery.

Methods: Adult patients presenting to a community hospital with a hip fracture requiring surgery were randomly assigned to receive topical TXA or placebo. Hemoglobin and troponin I levels were measured preoperatively and on postoperative days 1, 2 and 3. All postoperative blood transfusions were recorded. Complications, including acute coronary syndrome (ACS), venous thromboembolism (VTE), cerebrovascular accidents (CVA), surgical site infections (SSI) and 90-day mortality, were recorded.

Results: Data were analyzed for 65 patients (31 in the TXA group, 34 in the control group). Hemogloblin level was significantly higher on postoperative days 1 and 2 in the TXA group than in the control group. The difference in hemoglobin level between the groups was not statistically significant by postoperative day 3. Significantly fewer units of packed red blood cells were transfused in the TXA group (2 units v. 8 units); however, 2 of the units in the control group were given intraoperatively, and when these were excluded the difference was not significant. The incidence of ACS, CVA, VTE, SSI, transfusion and all-cause mortality at 90 days did not differ significantly between the groups.

Conclusion: Topical TXA reduces early postoperative blood loss after hip fracture surgery without increased patient risk.

Trial registration: Clinicaltrials.gov, no. NCT02993341.

Contexte:: L’acide tranexamique (TXA) a permis de réduire les pertes sanguines périopératoires lors de chirurgies orthopédiques non urgentes. On ne connaît pas précisément l’innocuité du TXA lors de chirurgies urgentes pour fracture de la hanche. Cette étude avait pour but d’évaluer l’efficacité et l’innocuité du TXA topique lors de chirurgies pour fracture de la hanche.

Méthodes:: Des patients adultes ayant consulté dans un hôpital communautaire pour une fracture de la hanche nécessitant une chirurgie ont été assignés aléatoirement soit au TXA topique, soit à un placebo. Les taux d’hémoglobine et de troponine I ont été mesurés avant, puis 1, 2 et 3 jours après l’intervention. Toutes les transfusions sanguines ont été consignées, ainsi que les complications, telles que le syndrome coronarien aigu (SCA), la thromboembolie veineuse (TEV), l’accident vasculaire cérébral (AVC), l’infection de la plaie opératoire et la mortalité à 90 jours.

Résultats:: Les données ont été analysées pour 65 patients (31 dans le groupe sous TXA et 34 dans le groupe témoin). Le taux d’hémoglobine était significativement plus élevé aux jours postopératoires 1 et 2 dans le groupe sous TXA que dans le groupe témoin. La différence de taux d’hémoglobine entre les groupes n’était plus statistiquement significative au 3e jour postopératoire. Un nombre significativement moindre d’unités de culots globulaires ont été administrées dans le groupe TXA (2 unités c. 8 unités); par contre, 2 des unités dans le groupe témoin ont été administré pendant l’intervention, et lorsqu’elles ont été exclues, la différence n’était plus significative. L’incidence des SCA, des AVC, des TEV, des infections de plaies, des transfusions et de la mortalité de toute cause à 90 jours n’a pas été significativement différente entre les 2 groupes.

Conclusion:: Le TXA topique réduit les pertes sanguines durant la période postopératoire immédiate après la chirurgie pour fracture de la hanche, sans exposer les patients à un risque accru.

Numéro d’enregistrement de la recherche:: ClinicalTrials.gov, no. NCT02993341.

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Conflict of interest statement

Competing interests: None declared.

Figures

Fig. 1
Fig. 1
Overview of study population. Consecutive patients presenting to Sault Area Hospital with hip fracture requiring surgery between November 2017 and February 2019 form the basis of the study. In the list of excluded patients, the values in parentheses indicate the number of patients who were excluded from the study for the listed reason but also met 1 or more additional exclusion criteria. For example, 24 patients were excluded from the study solely because they declined to participate; an additional 2 patients declined to participate and also met at least 1 other exclusion criterion. DVT = deep vein thrombosis; GFR = glomerular filtration rate; TXA = tranexamic acid; VTE = venous thromboembolism.
Fig. 2
Fig. 2
Adjusted hemoglobin levels on POD 1, 2 and 3 after hip fracture surgery. For POD 1, p = 0.005. For POD 2, p = 0.02. For POD 3, p = 0.06. POD = postoperative day.
See this image and copyright information in PMC

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