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28 (); 112-116
doi:
10.1016/j.jor.2021.11.018

Tranexamic acid use in pelvic and/or acetabular fracture surgery: A systematic review and meta-analysis

, , ,
a Department of Orthopaedic Surgery, The Johns Hopkins University, Baltimore, MD, USA
b Department of Neurology, The Johns Hopkins University, Baltimore, MD, USA

∗Corresponding author: Babar Shafiq. bshafiq2@jhmi.edu

Received: , Accepted: ,
Professor P K Surendran Memorial Education Foundation
Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

The purpose of this study is to determine whether tranexamic acid (TXA) use was associated with lower rates of blood transfusion in patients undergoing pelvic and/or acetabular fracture surgery.

Four studies were included, 3 of which were included in the pooled data analysis for a total of 308 patients.

The transfusion rate was significantly lower in the TXA group (44%) compared with the non-TXA group (57%) (P = 0.02).

TXA use was associated with a significantly lower transfusion rate in patients who underwent pelvic and/or acetabular fracture surgery.

Level 3. Systematic review of retrospective cohort studies and prospective randomized controlled trials.

Abstract

Highlights

•TXA use was associated with a lower transfusion rate in patients who underwent pelvic and/or acetabular fracture surgery.•No association was found between TXA use and intraoperative blood loss.•TXA use was not associated with higher rates of venous thromboembolism.

Keywords

Acetabulum fracture
Antifibrinolysis
Orthopaedic trauma
Pelvic fracture
Tranexamic acid
1

1 Introduction

Pelvic and acetabular fractures are complex injuries often associated with substantial hemorrhage.1–5 Given the high-energy mechanism of these injuries, mortality rates after pelvic/acetabular trauma are high, especially in patients with hemodynamic instability.6–8 Moreover, uncontrolled hemorrhage is the leading cause of death in pelvic/acetabular trauma, with mortality rates between 18% and 40% in hemodynamically unstable patients with pelvic fractures.9–11 Early definitive surgical treatment of pelvic/acetabular fractures leads to shortened hospital stays and reduces rates of postoperative complications and death.12–21 Given these benefits, antifibrinolytic medications have been considered to prevent blood loss during and after surgery.9,22,23 Tranexamic acid (TXA) is the most widely used antifibrinolytic medication and was shown to safely reduce bleeding in trauma patients in large multicenter civilian and military studies.24,25 TXA is a synthetic derivative of lysine that prevents fibrinolysis by binding to the lysine receptors on plasminogen, which prevents the enzyme from interacting with the lysine residues on fibrin.26 TXA has been used in general trauma surgery to reduce perioperative bleeding and the need for transfusions.27,28 TXA is routinely used in lower extremity total joint arthroplasty, with such use endorsed by the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, The Hip Society, and The Knee Society.29

Recent studies have supported TXA use in orthopaedic trauma surgery.30,31 Gausden et al.31 systematically reviewed and quantified the effectiveness of TXA in orthopaedic trauma surgery patients and found that TXA use was associated with significantly less blood loss and lower transfusion rates without an associated increase in the rate of symptomatic venous thromboembolism (VTE). Additionally, several other studies have reviewed TXA use in hip and femur fracture surgery, reporting that TXA use reduced transfusion rates without a significant increase in VTE rates.32–35

To our knowledge, no systematic review or meta-analysis has analyzed TXA use in patients with pelvic/acetabular fractures. Therefore, the purpose of this study was to investigate whether TXA use was associated with lower rates of blood transfusion in patients undergoing surgery for pelvic/acetabular fractures. The secondary aim was to determine whether TXA use was associated with higher rates of VTE. We hypothesized that TXA use would be associated with a lower rate of blood transfusions and no difference in the rate of VTE.

2

2 Methods

We searched the Cochrane Database of Systematic Reviews, Embase, and PubMed to identify studies analyzing TXA use in pelvic and/or acetabular fractures. Searches were conducted with the following Boolean string: [(“pelvic fracture” OR “acetabulum fracture”) AND “tranexamic acid”]. The search method is shown in Fig. 1.36 We included studies that 1) compared patients receiving TXA with a control group, 2) analyzed patients with pelvic and/or acetabular fractures, and 3) reported intraoperative blood loss, transfusion rates, and/or VTE rates. Overall VTE included deep vein thrombosis (DVT) and pulmonary embolism (PE). Regarding transfusions, the use of intraoperative Cell Saver (Braintree, MA, USA) was considered as a transfusion. Additionally, we included all both intraoperative and postoperative transfusions in our analysis. Eligible study types were randomized controlled trials (RCTs), prospective studies, and retrospective cohort studies. Additionally, studies involving patients with non-pelvic and non-acetabular fractures were included if the pelvic and acetabular fracture data could be analyzed separately. Articles published in English and in any year indexed were searched during October 2020. We excluded case studies, unpublished data, and studies that did not provide any of the previously specified outcomes. One study was excluded after full-text review because it was a conference abstract and the data were unpublished (Fig. 1).

Summary of study selection according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines 36. We searched PubMed, Embase, and the Cochrane Database of Systematic Reviews for studies analyzing the effects of tranexamic use in patients who underwent pelvic and/or acetabular fracture surgery.
Fig. 1 Summary of study selection according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines 36. We searched PubMed, Embase, and the Cochrane Database of Systematic Reviews for studies analyzing the effects of tranexamic use in patients who underwent pelvic and/or acetabular fracture surgery.

Two authors reviewed search results and excluded titles irrelevant to TXA use in pelvic/acetabular fractures. Abstracts of the remaining articles were independently reviewed, and qualifying articles were confirmed after review of the full text. Disagreements were resolved by consensus after review of the full-text manuscript.

2.1

2.1 Statistical analyses

Patient characteristics were recorded and analyzed when available. Data from individual studies were pooled using the algorithm and formulas as described in Cochrane's Handbook for Systematic Reviews of Interventions.37 Subsequent analyses used 2-sample proportion tests and 2-sample t tests to compare the number of events and means (±standard deviations) across treatment categories, respectively. Relative risk (RR) and number needed to treat were also calculated for overall VTE, DVT, and PE. Statistical analyses were performed using Stata, version 15, software (StataCorp LLC, College Station, TX). An α value of 0.05 was used.

3

3 Results

Four studies, with a total of 386 patients with pelvic and/or acetabular fractures, were included for review (Table 1). Spitler et al.38 was included in the review and discussion; however, their data were not pooled for analysis because subgroup patient characteristics, blood loss, transfusion rates, units of blood transfused, and VTE rates, including DVT and PE rates, were unavailable. Therefore, only 3 studies were included in pooled data analysis.39–41 Three of the 4 studies38,39,41 used intravenous administration of TXA, whereas 1 study40 used topical TXA (Table 1). Additionally, 3 studies38,40,41 had standardized dosing protocols for TXA, whereas 1 study39 did not. Lack et al.,41 Spitler et al.,38 and Cohen-Levy et al.39 included patients for whom intraoperative Cell Saver was used. Lack et al.41 included only 2 such patients, whereas Spitler et al.38 included 33 (18 in the TXA group and 15 in the control group, P = 0.57 via mid-P exact test). Cohen-Levy et al.39 considered the use of intraoperative Cell Saver as an intraoperative blood transfusion.

Table 1 Studies included in a systematic review of tranexamic acid use in pelvic and acetabular fracture surgery.
First author Year Study design Level of evidence Tranexamic acid administration Transfusion threshold No. (type) of fractures
Method Dose
Lack41 2017 Randomized controlled trial 1 Intravenous 10 mg/kg within 30 min before surgery, followed by an infusion of 10 mg/kg over a 4-h period during surgery Hemoglobin < 7 g/dL 88 (acetabular)
Kashyap40 2019 Retrospective cohort study 3 Topical 3 g in 100 mL normal saline Hemoglobin < 8 g/dL 61 (acetabular)
Spitler38 2019 Randomized controlled trial 1 Intravenous 15 mg/kg preoperatively and an additional 15 mg/kg 3 h after the initial dose Hemoglobin < 8 g/dL 78a (pelvic or acetabular)
Cohen-Levy39 2020 Retrospective cohort study 3 Intravenous Tranexamic acid use was at the discretion of the attending surgeon and anesthesiologist. No institutional protocols were in place. At the discretion of the attending surgeon and anesthesiologist; no institutional protocols were in place 159 (50 isolated pelvic ring, 92 isolated acetabulum, 17 combined)
a Expressed as number of patients.

Of the 3 studies included in pooled data analysis, 308 patients had pelvic and/or acetabular fractures (TXA group, N = 119; non-TXA group, N = 189). Of these injuries, 67 (22%) were pelvic ring injuries (isolated, N = 50; combined pelvic and acetabular fractures, N = 17). Two studies included only acetabular fractures (N = 149).40,41

No significant differences were found between the TXA and non-TXA groups regarding age, sex, body mass index, acetabular fracture patterns, or operative time (Table 2). We did not assess comorbidities because some studies did not report comorbidities for each group.

Table 2 Pooled characteristics and outcomes of operative treatment of pelvic and acetabular fractures, by intraoperative use of TXA.
Parameter TXA (N = 119) No TXA (N = 189) Pa
N (%) Mean ± SD N (%) Mean ± SD
Age, years 44 ± 17 41 ± 18 0.16
Female sex 37 (31) 61 (32) 0.83
Body mass indexb, kg/m2 32 ± 9.3 31 ± 8.7 0.42
Acetabular fracture patternb
Associated 35 (48) 29 (41) 0.23
Elementary 38 (52) 41 (59) 0.23
Operative time, min 232 ± 93 233 ± 103 0.94
Units of blood transfusedc 2.3 ± 1.2 2.4 ± 1.1 0.55
No. of patients transfused 52 (44) 108 (57) 0.02
Operative blood loss, mL 569 ± 495 559 ± 404 0.85
Venous thromboembolism 4 (3.4) 14 (7.4) 0.14
Deep vein thrombosis 2 (1.7) 9 (4.8) 0.16
Pulmonary embolism 2 (1.7) 5 (2.6) 0.58
a From 2-sample tests of proportions and 2-sample t tests for categories involving number of events and mean (±standard deviation), respectively.
b Cohen-Levy et al.39 did not report body mass index or fracture pattern data for either treatment group; thus, that study was excluded from those analyses.
c Kashyap et al.40 did not report units of blood transfused data; thus, that study was excluded from that analysis.

No significant differences between groups were found in intraoperative blood loss (P = 0.85) or units of blood transfused (P = 0.55) (Table 2). The transfusion rate was significantly lower in the TXA group (44%) compared with that of the non-TXA group (57%) (P = 0.02). A total of 18 VTEs (5.8%) occurred (TXA group, N = 4; non-TXA group, N = 14) (Table 2). No significant differences were found between groups in rates of overall VTE, DVT, or PE. RRs were 0.45 for overall VTE (95% confidence interval [CI] 0.15–1.4), 0.35 for DVT (95% CI, 0.08–1.6), and 0.64 for PE (95% CI, 0.13–3.2). The number needed to treat was 25 for overall VTE, 33 for DVT, and 104 for PE.

We did not perform a subanalysis of the 2 randomized controlled trials because additional data, as described above, were unavailable for the study by Spitler et al.38

4

4 Discussion

The most important finding of this study was that TXA use in pelvic/acetabular fracture surgery was associated with a significantly lower transfusion rate compared with the control group. Furthermore, TXA use was not associated with higher risk of VTE. These results suggest that TXA may be a safe and effective treatment to decrease the need for blood transfusions in patients with pelvic/acetabular fractures.

Although the pooled results in our study indicate that TXA use is associated with a decrease in transfusion rate, only 1 study in our analysis reported a significantly lower transfusion rate.40 The 2 RCTs we included had conflicting conclusions regarding TXA use in patients with pelvic/acetabular fractures. Lack et al.41 reported no significant difference in intraoperative blood loss, transfusion rates, or VTE, including DVT and PE, with TXA use; whereas, Spitler et al.38 reported significantly less total blood loss with TXA and no differences in transfusion and VTE rates, including DVT and PE. Additionally, Spitler et al.38 included in their cohort 23 patients who had femoral fracture without pelvic or acetabular fracture, which makes it difficult to interpret their findings regarding pelvic/acetabular fractures. Similar to Spitler et al.,38 Kashyap et al.40 reported a significant reduction in intraoperative blood loss with TXA use. Cohen-Levy et al.39 did not assess intraoperative blood loss. Although Cohen-Levy et al.39 identified that TXA use was associated with a significantly lower number of units of blood transfused, we found no such difference in our analysis. The results of our study demonstrate no significant difference in intraoperative blood loss with the use of TXA.

Furthermore, TXA use was not associated with an increase in overall VTE, DVT, or PE rates or risk. Our study is consistent with all of the included studies: no study reported increased risk of overall VTE, DVT, or PE with the use of TXA. However, it is important to note the different methods used for VTE diagnosis in these studies. Only Spitler et al.38 and Cohen-Levy et al.39 reported using a standardized screening process for diagnosing DVTs and PEs. Kashyap et al.40 and Lack et al.41 reported only symptomatic DVTs and PEs. Additionally, the method of screening varied between studies: Spitler et al.38 performed DVT screening with duplex ultrasonography for patients who were hospitalized for 7 days, and Cohen-Levy et al.39 reported DVT screening via duplex ultrasonography and PE screening via computed tomography angiogram of the chest or ventilation/perfusion scan at the discretion of the trauma care team.

There was heterogeneity in the administration of TXA in the studies included in our review. Kashyap et al.40 used topical TXA, whereas the other 3 studies38,39,41 used intravenous TXA. Moreover, Cohen-Levy et al.39 did not use a standardized method of TXA administration because the dosing and administration of TXA were at the discretion of the surgeon and anesthesiologist. Spitler et al.38 used a 5-mg/kg higher dose than Lack et al.41 and administered the second dose 3 h after the initial dose instead of intraoperatively. The most effective delivery method and dosing protocol for TXA in patients undergoing orthopaedic trauma surgery are unknown.31 The CRASH-2 Trial, a randomized controlled trial of TXA use in more than 20,000 trauma patients with substantial hemorrhage, did not use a weight-based dosing regimen but instead used a 1-g dose of TXA administered over 10 min as a loading dose, followed by intravenous infusion of 1 g of TXA administered over 8 h for all patients.25 Additionally, topical TXA has been shown to be as effective as intravenous TXA in total joint arthroplasty.42,43 Gausden et al.31 also reported no significant difference in the risk of blood transfusion between topical and intravenous TXA in orthopaedic trauma patients. Further studies are needed to compare TXA dosing methods, quantities, and routes of administration in orthopaedic trauma patients, as well as specifically for patients undergoing fixation of pelvic and/or acetabular fractures.

Our results are consistent with those of the meta-analysis by Gausden et al.,31 who found that TXA use was associated with reduced transfusion rates in orthopaedic trauma patients without an increase in VTE risk. Previous meta-analyses of TXA use in orthopaedic surgery have also identified a significant reduction in blood loss and transfusion rates with TXA use in spine surgery44–46 and total joint arthroplasty.47 Nonetheless, the authors concluded that TXA use was not associated with an elevated rate of overall VTE, DVT, or PE, which is consistent with our findings.

4.1

4.1 Limitations

Our study was limited by the number and quality of studies available for review and data analysis. We were unable to perform a subanalysis of RCTs because the data from Spitler et al.38 were unavailable for pooled analysis. Additionally, differences in transfusion thresholds and TXA administration and dosing among the studies makes interpreting these results challenging. We were also unable to pool data regarding changes in hemoglobin or hematocrit as studies did not consistently report postoperative changes in hemoglobin. Furthermore, only Cohen-Levy et al.39 provided subclassification of pelvic fracture types, thus limiting our ability to analyze differences in pelvic fracture classification in our pooled data. The use of intraoperative Cell Saver also makes interpretation of intraoperative blood loss challenging because the Cell Saver can reduce the need for allogeneic transfusion. Nevertheless, to our knowledge, this is the largest systematic review and first meta-analysis of TXA use in patients who underwent surgery for pelvic and acetabular fractures.

5

5 Conclusion

Compared with the non-TXA group, TXA use was associated with a significantly lower transfusion rate in patients who underwent pelvic and/or acetabular fracture surgery. No associations were found between TXA use and intraoperative blood loss or total units of blood transfused. Similarly, TXA use was not associated with higher rates or risk of VTE, DVT, or PE.

FUNDING

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Funding

No funding was received in support of this work.

Role of funder

N/A.

Declaration of interest

Babar Shafiq, MD, MSPT is a paid consultant for DePuy Synthes and Bone Foam.

The rest of the authors have no relevant financial disclosures.

Ethical review

This study was exempt from institutional review board approval. Patient consent was not required for this study.

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