The use of tranexamic acid in open elbow release surgery

Abstract

Background

Tranexamic acid (TXA) has been effective in reducing perioperative blood loss in hip, knee, and shoulder arthroplasty. Our purpose was to assess the effect of TXA on perioperative blood loss for open elbow release.

Methods

Consecutive open elbow releases performed between October 2016 and March 2020 were identified. Patients were included if both anterior and posterior joint releases with a single medial approach was performed. From November 2018 onward, intravenous TXA and topical TXA infused through a deep hemovac drain were administered as part of the perioperative protocol. Drain output, intraoperative blood loss, postoperative aspiration rate, and postoperative transfusion frequency were assessed.

Results

Fifty patients (25 TXA, 25 non-TXA) were included. Drain output was significantly lower in the TXA-treated group compared to the non-treated group (121 mL vs. 221 mL; p = 0.003). There was no significant difference in intraoperative blood loss and the incidence of postoperative aspiration between groups. None of the patients received a blood transfusion or had a documented thromboembolic event.

Discussion

The use of tranexamic acid with open elbow release surgeries resulted in decreased drain output, with no thromboembolic events. Perioperative tranexamic acid can be a safe and effective modality in reducing perioperative blood loss for open elbow release surgery.

Introduction

Tranexamic acid (TXA) is a synthetic agent that impedes conversion of plasminogen to plasmin, inhibiting fibrinolysis and clot degradation.^1,2 Within the orthopedic literature, TXA has been shown to be safe and effective in reducing perioperative blood loss in spine surgery, ³ as well as hip,^4–6 knee,^4,6–8 and shoulder arthroplasty.^1,9–16

There are no reports regarding the efficacy of TXA in open elbow release surgery, a procedure that can have notable perioperative blood. The purpose of this study was to compare perioperative blood loss in a cohort of patients treated with or without perioperative TXA for open elbow release with bony debridement by a single surgeon using a standard operative protocol. We hypothesized that similar to prior studies in the arthroplasty literature, the TXA-treated group would experience less perioperative blood loss compared to the non-treated group.

Materials and methods

This study was approved by our Institutional Review Board. We retrospectively identified all patients who underwent open elbow release with bony debridement for osteoarthritis between October 2016 and March 2020 by a single fellowship trained hand and upper extremity surgeon. To help standardize both groups, patients were included if the procedure involved both anterior and posterior joint releases with a single medial approach. Patients were excluded if hardware was removed, or if a combined medial and lateral approach was utilized. Since November 2018, perioperative TXA treatment has been implemented in all elbow release patients with the exception of those with a history of prior venous thromboembolism, myocardial infarction, or cerebrovascular accident. Patients treated with TXA received an intravenous (IV) dose of TXA (1 g) within 30 min of incision. Additionally, a single topical dose of TXA (1 g in 20 mL saline solution) was infused through a deep hemovac drain after fascial closure. This combination of IV and topical TXA administration was chosen based on a prior study which demonstrated less hidden blood loss in patients undergoing total knee arthroplasty treated with combined IV and topical TXA. ⁸

A standard medial elbow approach under tourniquet control was utilized.^17,18 The incision extended from the posterior aspect of the intermuscular septum, through the cubital tunnel, and into the proximal forearm. Full-thickness flaps were elevated to expose the medial epicondyle and flexor-pronator origin. The medial antebrachial nerve branches were protected and the ulnar nerve was released and retracted anteriorly. For posterior joint exposure, the triceps was elevated off of the intermuscular septum, humerus, and joint capsule. The posterior joint capsule was excised; the olecranon fossa was debrided, deepened, and cleared of loose bodies; and the olecranon tip was removed if needed. For anterior joint exposure, dissection was extended along the supracondylar ridge and then distally through the posterior one-third interval of the flexor-pronator origin. The flexor-pronator mass and brachialis were elevated off of the anterior capsule as a single sleeve. The anterior capsule, once isolated, was excised; the coronoid and radial fossae were debrided, deepened, and cleared of loose bodies; and the coronoid tip was removed if needed. The ulnar nerve was transposed anteriorly in a subcutaneous position and the intermuscular septum was resected. Following the joint release, the tourniquet was released and hemostasis was achieved anteriorly and posteriorly. In all cases, an identical hemovac drain was placed deep to the triceps in the olecranon fossa, after which the fascia was closed. In the TXA-treated group, the topical TXA (1 g in 20 mL saline solution) was then injected into the drain tubing, which was subsequently clamped. This method allowed for the application of topical TXA within the enclosed space. Soft-tissue layers were closed, and soft dressings were applied. In both groups, the hemovac drain was then assembled and placed to suction. Intraoperative blood loss was estimated in conjunction with anesthesia based on the amount of suction drainage, factoring in irrigation used during the case.

All patients were admitted overnight with identical postoperative protocols in both groups.^18,19 Continuous passive motion (CPM) was initiated in the recovery room, and ice and elevation was encouraged to reduce swelling. Drain output was measured and documented in the electronic medical record by nursing staff. In all patients, the drain and bulky dressing were removed on the first postoperative day at approximately 24 h after placement, and patients were fitted for a compression sleeve to limit swelling.^18,19 Formal therapy was initiated on postoperative day one for active and gentle passive elbow motion combined with intermittent CPM (twice daily for 30 min per session).^18,19 Weighted passive stretches using a 2-lb wrist weight with the arm extended over a bolster were performed 10 to 15 min several times per day in order to help maintain extension.^18,19 Static progressive elbow bracing was also initiated after the first postoperative day, with patients wearing the brace for approximately 30 min, two or three times per day, alternating flexion and extension based on the preoperative deficit and progress.^18,19 Indomethacin 75 mg twice daily was prescribed for three weeks postoperatively for prophylaxis of heterotopic ossification.^18,19 Patients were typically discharged on the first postoperative day with physical therapy and instructions to perform the previously detailed exercises and bracing several times per day.^18,19 CPM was typically discontinued after 3–4 weeks, and dynamic bracing was continued for several months as needed.^18,19

Total drain output, intraoperative blood loss, as well as the need for postoperative blood transfusion was recorded. At the first follow-up appointment, eight days postoperatively, the need for elbow aspiration was assessed by the operating surgeon. Aspiration was performed if there was a subcutaneous hematoma that was felt to be limiting terminal elbow flexion or extension. The incidence and frequency of aspiration and documented postoperative thromboembolic events was assessed for all patients.

A power analysis conducted prior to data analysis demonstrated that 16 patients were required in each group in order to have 80% power to detect a 100-mL difference in total drain output, accepting a type-I error rate of 0.05.

Statistical analysis was performed using Stata 14.1 Statistical Software (StataCorp, 2016. Stata Statistical Software: Release 14.1. College Station, TX: StataCorp LP). Unpaired Student’s t tests for continuous variables and Fischer’s exact tests for categorical variables were used to compare age, gender, and operative time between TXA and non-TXA groups. Unpaired Student’s t tests for continuous variables and Fischer’s exact tests for categorical variables were used to compare total drain output, intraoperative blood loss, postoperative aspiration rate, and postoperative transfusion frequency between TXA and non-TXA groups. The level of significance was set at p < 0.05 and a two-tailed test was used in all cases.

Results

A total of 50 patients met inclusion criteria for this study, of which 25 received perioperative TXA treatment and 25 did not receive perioperative TXA treatment. The groups were similar with regard to age, gender, and operative time (p > 0.05 for all; Table 1).

Table 1.

Patient and surgical characteristics. ^a

	TXA (n = 25)	Non-TXA (n = 25)	p value
Age (years)	45 ± 13	45 ± 15	0.953
Male	20 (80%)	18 (72%)	0.742
Operative time (min)	122 ± 24	123 ± 18	0.725

TXA: tranexamic acid.

^aData are expressed as mean ± standard deviation or number (percentage).

Total drain output was significantly lower in the TXA treatment group (121 ± 88 mL, range 15–360 mL) compared to the non-TXA treatment group (221 ± 134 mL, range 50–580 mL; p = 0.003; Table 2). Intraoperative blood loss was similar between the TXA-treated group (31 ± 21 mL, range 10–100 mL) and non-TXA-treated group (37 ± 28 mL, range 5–100 mL; p = 0.476). There was no statistically significant difference in the incidence of postoperative aspiration between the TXA and non-TXA treatment groups (8% vs. 20%; p = 0.417). No patient required a blood transfusion or had a documented thromboembolic event.

Table 2.

Perioperative blood loss. ^a

	TXA (n = 25)	Non-TXA (n = 25)	p value
Total drain output (mL)	121 ± 88	221 ± 134	0.003*
Intraoperative blood loss (mL)	31 ± 21	37 ± 28	0.476
Postoperative aspiration	2 (8%)	5 (20%)	0.417

TXA: tranexamic acid.

^aData are expressed as mean ± standard deviation or number (percentage).

*Statistical significance based on alpha level 0.05.

Discussion

This study evaluates the influence of perioperative TXA treatment on perioperative blood loss in patients undergoing open elbow release with bony debridement for osteoarthritis. We found that the TXA treatment group had significantly less total drain output (100 mL) compared to the non-TXA-treated group, with no significant difference in intraoperative blood loss between groups. Postoperatively, there was a trend toward a decreased need for aspiration in the TXA treatment group compared to the non-TXA-treated group (8% vs. 20%), though this difference was not statistically significant. No patient in either group required a blood transfusion. These results suggest that perioperative treatment with combined IV and topical TXA is effective in reducing perioperative blood loss in open elbow release surgeries with bony debridement.

This study’s overall findings are consistent with prior work in the hip, knee, and shoulder arthroplasty literature.^1,4–16 With regard to total drain output, Vara et al. found a decrease of approximately 150 mL in drain output in patients undergoing reverse total shoulder arthroplasty who received IV TXA compared to those who did not receive TXA. ¹⁶ Kirsch et al., in a meta-analysis of shoulder arthroplasty patients, demonstrated a drain output decrease of 117 mL in patients who received TXA compared to those who did not. ¹ Our study similarly found decreased drain output with TXA administration. While our trend towards decreased postoperative aspiration rates between the two groups did not reach statistical significance, this may have been due to a lack of power. Pauzenberger et al., in a randomized controlled trial evaluating the use of TXA in shoulder arthroplasty, reported that hematomas in the TXA-treated group occurred less often compared to the placebo group (26% vs. 59%), and they were described as “mild”. ¹⁵ Further study with larger sample sizes would be necessary to determine the true effect of TXA treatment on the severity of postoperative hematomas and the incidence of aspiration in open elbow release procedures.

We found no significant differences in intraoperative blood loss between the TXA and non-TXA-treated groups. This is not unexpected, as a tourniquet was used in all cases. The similarities in blood loss and operative times between the groups suggest that the two groups were similar in regards to severity of elbow pathology.

No patients in either group required a blood transfusion. Though TXA treatment has been shown to significantly reduce the risk of blood transfusion in the hip and knee arthroplasty literature,^4,5,7 elbow release surgeries do not typically result in sufficient blood loss to require blood transfusion.

Mannan et al. reported a case series of 10 patients undergoing total elbow arthroplasty who received TXA, reporting no blood transfusions and no signs of infection at six weeks. ²⁰ Though this study did not include a control group, our study similarly found that no blood transfusions were necessary.

Given the antifibrinolytic nature of TXA, a valid concern is whether there is an associated increased risk for venous or arterial thromboembolic events. This study demonstrated no thromboembolic events in either group, suggesting TXA may be safe when used for open elbow releases. It is important to note that our study did not use TXA in patients with a history of prior venous thromboembolism, myocardial infarction, or cerebrovascular accident. Fillingham et al. conducted a meta-analysis to evaluate the safety of TXA in primary total hip and knee arthroplasty patients, reporting no increased risk of venous thromboembolism associated with the use of topical, IV, or oral TXA. ⁶ Those authors additionally analyzed patients with an ASA grade of 3 or greater, noting no associated increased risk of venous thromboembolism after total knee arthroplasty. ⁶ The American Association of Hip and Knee Surgeons suggested in their clinical practice guidelines that patients with known risk factors for thromboembolism should be considered individually and with a multidisciplinary approach when considering the use of TXA. ⁴

This study utilized a TXA treatment protocol with administration of preoperative IV TXA (1 g) and intraoperative topical TXA (1 g in 20 mL saline solution) infused into a drain. Huang et al. reported less hidden blood loss and a lower ratio of postoperative knee swelling in total knee arthroplasty patients treated with IV (20 mg/kg prior to skin incision and 10 mg/kg 3, 6, 12, and 24 h later) and topical TXA (1 g topical TXA in 50 mL normal saline) without a tourniquet compared to those who did not receive TXA and had a tourniquet. ⁸ The dosing and method of administration of TXA has been extensively studied in the hip and knee arthroplasty literature, and no formulation has demonstrated significant superiority.^4,5,7 As such, the results of our study are limited to our method of TXA administration with IV and topical formulations.

Limitations of this study include its retrospective nature, in that the TXA treatment group was preceded by the non-TXA treatment group. It is possible that the additional experience gained while treating the non-TXA group may have led to improved surgical technique and hemostasis in the subsequent TXA-treated group. However, the treating surgeon has over 25 years of experience with open elbow release, and the additional experience gained during the several months of data collection is unlikely to have biased the results. Another study limitation is the variation in elbow pathology between treatment groups resulting in possible differences of perioperative blood loss. However, attempts at group standardization were made by including patients only with osteoarthritis in which surgery was performed through a single medial approach by a single surgeon with a uniform protocol. Other limitations of this study include the infusion of the 20 mL topical TXA solution into the deep hemovac. It is likely that some of this infused solution was evacuated from the drain and recorded in the drain output. We chose not to subtract 20 mL from the drain output for each TXA-treated patient, as we realize that some of the solution may have been resorbed into the soft tissues and it is unlikely that all of 20 mL was evacuated in each patient. Therefore, the observed drain output in the TXA treatment group is likely greater than the actual drain output, even further favoring the efficacy of TXA treatment.

The use of IV and topical tranexamic acid in open elbow release resulted in significant decreased total drain output, and lower incidence of elbow aspiration with no thromboembolic events. Perioperative tranexamic acid may be a safe and effective modality in reducing perioperative blood loss for open elbow release surgery with bony debridement. Further prospective study with randomization, larger sample sizes, and analysis of postoperative hemoglobin is warranted.