Tranexamic Acid Reduces Transfusion Requirements After Pelvic Osteotomy: A Nationwide Propensity Score–Matched Analysis

doi:10.21203/rs.3.rs-8432750/v1

Introduction: Pelvic osteotomy is frequently associated with substantial perioperative blood loss due to the highly vascularized pelvic anatomy. Tranexamic acid (TXA) is widely used to reduce blood loss in total hip arthroplasty; however, evidence supporting its use in pelvic osteotomy, particularly in Asian populations, remains limited. This study evaluated the association between perioperative TXA use, transfusion requirements, and postoperative complications in patients undergoing pelvic osteotomy in Japan.

Materials and Methods: Using the Japanese Diagnosis Procedure Combination (DPC) nationwide administrative database, we retrospectively identified patients who underwent pelvic osteotomy between December 2011 and March 2023. Patients receiving perioperative TXA were compared with those who did not, using one-to-one propensity score matching. Outcomes included transfusion rates on postoperative days 0–2, cumulative transfusion volume, and in-hospital complications, including infection, deep vein thrombosis (DVT), pulmonary embolism (PE), and reoperation.

Results: After matching, 3,542 patients were included in each group. TXA use was independently associated with a significantly lower likelihood of blood transfusion on postoperative days 0 (95% CI, 0.552–0.693; p < 0.05) and 1 (95% CI, 0.472–0.579; p < 0.05). The cumulative transfusion volume over the first three postoperative days was significantly lower in the TXA group than in the non-TXA group (598.8 ± 408.0 g vs. 728.6 ± 426.5 g; p < 0.05). While autologous transfusion use differed, allogeneic transfusion rates were comparable. No significant increase in infection, PE, or reoperation was observed, and TXA was not associated with a clinically relevant increase in thromboembolic events.

Conclusions: Perioperative TXA use was associated with reduced transfusion requirements after pelvic osteotomy without compromising short-term safety, supporting its use within contemporary perioperative management in Japan.

Acetabular dysplasia is the leading cause of hip osteoarthritis[10]. Successful long-term outcomes for various osteotomies have been reported[11; 13; 14; 21; 24; 34], one of the major causes for postoperative morbidity is peri- and postoperative blood loss. Given that the osteotomy is performed in the pelvis, which is richly vascularized, the procedure is often accompanied by significant blood loss, sometimes necessitating allogeneic blood transfusion[23; 31]. Allogeneic blood transfusion is not without risk and has been associated with blood-borne infections, transfusion-related complications, increased rates of hardware infection, prolonged length of hospital stay, and higher healthcare costs[2; 3; 9].

Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that has gained widespread acceptance in orthopedic surgery due to its proven effectiveness in reducing perioperative blood loss by inhibiting fibrinolytic activity[12]. Numerous studies, including randomized controlled trials, have shown that TXA effectively reduces intraoperative blood loss and transfusion requirements in total hip arthroplasty through various administration methods[1; 6–8; 16; 20; 22; 25; 30; 32; 35; 36]. In pelvic osteotomy procedures, which are associated with substantial bleeding due to multiple osteotomies in a highly vascularized region, multiple studies have demonstrated that TXA effectively reduces perioperative blood loss and the need for allogeneic transfusion[4; 15; 28; 29; 31; 33]. Although evidence supports the efficacy and safety of TXA in pelvic osteotomies, most available data are derived from Western populations, and real-world evidence from Asian countries, including Japan, remains limited. Differences in patient demographics, perioperative management strategies, and baseline thromboembolic risk across regions underscore the need to validate these findings in a Japanese clinical setting. The Japanese Diagnosis Procedure Combination (DPC) database provides a large, nationwide administrative dataset that enables a comprehensive assessment of perioperative practices and outcomes. Accordingly, the present study investigated the association between perioperative TXA use and transfusion requirements as well as postoperative complications in patients undergoing pelvic osteotomies using real-world data from this national database.

Study design

This study utilized data from the Japanese Diagnosis Procedure Combination (DPC) database and was conducted in accordance with the ethical principles of the Declaration of Helsinki. Ethical approval was obtained from the Institute of Science Tokyo (approval No. M2000-788) and the Tohoku University Graduate School of Medicine (approval Nos. 2021-1-1082 and 2024-1-1026). All data were retrospectively extracted from the national DPC administrative claims database. The anonymized dataset includes hospital identifiers, patient demographics, diagnoses coded according to the International Classification of Diseases, 10th Revision (ICD-10), admission and discharge dates, discharge status, operative procedures, and pharmaceutical use. Additionally, the database separately records admission diagnoses, comorbidities present at admission, and complications that arise during hospitalization. The study period spanned from December 2011 to March 2023, covering a nationwide cohort of hospitals operating under the DPC system. During this timeframe, approximately 1,100 participating hospitals routinely submitted medical records and consented to their use for research purposes. Patients who underwent pelvic osteotomy at any of these institutions were included, allowing for a comprehensive assessment of the real-world landscape of pelvic osteotomy practice across Japan. The inclusion surgeries were defined as follows: (1) transposition osteotomy of the acetabulum (computerized receipt processing system code: 150050410), (2) pelvic osteotomy (150064710), and (3) shelf acetabuloplasty (150064810). The primary diagnoses were categorized using ICD-10 codes, (1) with osteoarthritis of the hip; codes as M160-169 with diseases requiring the most medical resources, (2) remaining congenital dislocation of the hip or acetabular dysplasia; codes as Q650 to 653, 658. Patients undergoing femoral osteotomy or hip arthroscopy simultaneously were excluded from the analysis. A total of 8,499 patients who met the inclusion and exclusion criteria were analyzed. Outcomes of interest included transfusion rates on postoperative day 0 (day of surgery), day 1, and day 2, as well as the occurrence of postoperative infection, deep vein thrombosis (DVT), pulmonary embolism (PE), and reoperation.

Data selection

In this study, we compared pelvic osteotomy patients who received perioperative TXA with those who did not. Use of TXA was extracted from medication codes used on the day of surgery. One-to-one Propensity Score (PS) matching was performed between pelvic osteotomies with TXA and without TXA. The covariates used for confounding adjustment included age, sex, body mass index (BMI), type of surgeries, and Charlson Comorbidity Index (CCI). After one-to-one PS matching, 3,542 patients were included in both pelvic osteotomies with TXA and without TXA. C-statistics were used to assess the discriminative power of the models. PS estimates were used to perform nearest-neighbor matching without replacement, with the PS estimates serving as calipers; the caliper was set to 0.2 times the PS estimate's standard deviation. The C-statistic was 0.9076, and all covariates except for postoperative anticoagulated agent had standardized mean differences (SMDs) < 0.1, confirming adequate balance (Table 1). This resulted in matched pairs and the establishment of PS-matched pelvic osteotomies with TXA and without TXA groups. The patient selection process is shown in Fig. 1.

Statistical Analysis

All data are presented as means with standard deviations. Differences between the two groups were assessed using the χ² test for categorical variables and Student's t-test for continuous variables, as appropriate. The Shapiro-Wilk test was used to evaluate normally distributed variables. Univariate logistic regression analyses were performed to examine the association between TXA use and the following outcomes: transfusion on postoperative day 0, day 1, and day 2; postoperative infection; DVT; PE; and reoperation. Variables with a P value < 0.25 in the univariate analyses were entered into the multivariate logistic regression models to adjust for potential confounders, in accordance with the approach[5]. All statistical tests were two-tailed, and P-values < 0.05 were considered statistically significant. In addition, the standardized mean difference (SMD) between the two groups was calculated; SMDs < 0.1 were considered statistically no difference. All analyses were performed using JMP version 18.0 (SAS, Cary, North Carolina, USA).

The association between TXA use and perioperative blood transfusion was examined using multivariable logistic regression analysis (Table 2). TXA administration was independently associated with a significantly lower likelihood of blood transfusion on postoperative day 0, day 1, and day 2. The adjusted odds ratios (ORs) for transfusion were 0.619 (95% Confidence Interval [CI], 0.552–0.693; p < 0.05) on day 0, and 0.523 (95% CI, 0.472–0.579; p < 0.05) on day. In addition, the cumulative volume of transfused blood over the first three postoperative days was significantly lower in patients who underwent pelvic osteotomies with TXA compared with those without TXA (598.8 ± 408.0 g vs. 728.6 ± 426.5 g; p < 0.05). In contrast, despite a significant difference in the utilization of autologous blood transfusion between the two groups, the utilization of allogeneic blood transfusion was comparable (Table 3).

The use of TXA was associated with a significantly higher risk of DVT; no significant associations were found in the infection, PE, or reoperation during hospitalization (Table 2).

The present nationwide propensity score–matched study demonstrated that perioperative administration of TXA was significantly associated with reduced blood transfusion requirements in patients undergoing pelvic osteotomy in Japan. Notably, TXA use was independently associated with a lower likelihood of blood transfusion on postoperative day 0, day 1, and day 2, with the reduction being primarily driven by a decreased need for autologous blood transfusion, while the rate of allogeneic blood transfusion remained comparable between the groups. Importantly, TXA administration was not associated with an increased risk of postoperative complications, including surgical site infection, deep vein thrombosis, pulmonary embolism, or reoperation. To our knowledge, this study represents the largest real-world analysis evaluating TXA use in pelvic osteotomy and provides important evidence from an Asian population using a nationwide administrative database. Together with previous DPC-based studies on degenerative diseases, rheumatoid arthritis, and proximal femoral fractures, the present study contributes to a more comprehensive understanding of overall trends and characteristics of orthopedic care in Japan[5; 17–19; 26; 27].

Our findings are consistent with previous single-center and multicenter studies conducted predominantly in Western countries, which have demonstrated that TXA effectively reduces perioperative blood loss and transfusion requirements in pelvic osteotomy procedures. Bryan et al. reported that intravenous TXA completely eliminated the need for allogeneic transfusion in patients undergoing periacetabular osteotomy (PAO), compared with a 21% transfusion rate in controls, without increasing thromboembolic events[4]. Similarly, Wingerter et al. showed a significant reduction in estimated blood loss and transfusion rates after routine implementation of TXA during PAO, again without symptomatic DVT or PE[31]. High-level evidence has also been provided by Levack et al. in a randomized, double-blind, placebo-controlled trial, demonstrating that intravenous TXA reduced calculated blood loss by approximately 300 mL and decreased the rate of allogeneic transfusion by 73% following PAO[15]. In addition, Wassilew et al. reported a marked reduction in transfusion rates (62.5% vs. 12.5%) and total blood loss with continuous TXA infusion during PAO, without an increased risk of venous thromboembolism[29]. Beyond individual cohort studies, a systematic review and meta-analysis by Yao et al. demonstrated that TXA significantly reduced total blood loss and transfusion rates in PAO, without increasing wound complications or thromboembolic events[33]. Taken together, these studies provide robust evidence supporting the efficacy and safety of TXA in pelvic osteotomy. Our results extend these findings by confirming similar benefits in a nationwide Japanese cohort under real-world clinical conditions.

Although TXA is widely adopted in total hip arthroplasty[1; 6–8; 16; 20; 22; 25; 30; 32; 35; 36], its use in pelvic osteotomy has not yet been standardized in Japan. This is partly attributable to the limited availability of Japan-specific evidence and ongoing concerns about thromboembolic risk. In addition, differences in patient characteristics, perioperative blood management strategies, and baseline thromboembolic risk between Western and Asian populations underscore the need to validate previous findings within a Japanese clinical context. The present study provides robust real-world evidence demonstrating that TXA effectively reduces transfusion requirements without compromising safety in Japanese patients undergoing pelvic osteotomy. Notably, the reduction in transfusion volume was consistently observed across multiple postoperative time points (postoperative days 0–2), suggesting that TXA not only decreases intraoperative blood loss but also contributes to sustained postoperative hemostasis.

Consistent with previous studies on PAO[15; 29; 31], we observed no significant increase in postoperative DVT or PE associated with TXA use. This finding is in line with extensive evidence from arthroplasty and trauma surgery indicating that TXA does not increase thromboembolic risk when used appropriately. Taken together, our results support the safety of TXA in pelvic osteotomy within contemporary perioperative management protocols in Japan.

The major strengths of this study include the large sample size, nationwide coverage, and use of propensity score matching to minimize confounding between TXA and non-TXA groups. The DPC database enables a comprehensive assessment of perioperative transfusion practices and short-term postoperative complications across diverse institutions, enhancing the generalizability of our findings.

Several limitations of this study should be acknowledged. First, this analysis was restricted to patients treated at institutions participating in the Japanese DPC system, thereby excluding procedures performed in non-DPC–reporting beds, which account for approximately 30% of general hospital beds in Japan. Consequently, although the DPC database provides broad nationwide coverage, some degree of selection bias cannot be entirely excluded. Second, despite rigorous propensity score matching, residual confounding due to unmeasured variables remains possible. The DPC database lacks detailed clinical and operative information, including TXA timing, and route of administration, intraoperative blood loss, operative time, surgical approach, anesthesia protocols, laboratory data such as hemoglobin levels, postoperative anticoagulation regimens, and rehabilitation protocols. These factors may have influenced transfusion practices and postoperative outcomes, but could not be adjusted for in the present analysis. Third, outcome assessment was limited to in-hospital events. Long-term outcomes, including delayed thromboembolic events, late infections, functional recovery, and patient-reported outcomes, could not be evaluated. Prospective studies with extended follow-up are therefore warranted to comprehensively assess the long-term safety and clinical impact of TXA use in pelvic osteotomy, particularly in non-Western populations. Finally, as with all administrative databases, inaccuracies or omissions in diagnostic and procedural coding may have led to misclassification. Although the identification of TXA use based on medication codes is considered reasonably reliable, it may not capture all instances of administration. In addition, the severity of postoperative complications cannot be assessed due to the absence of detailed clinical information, and certain events that are difficult to capture using administrative codes may have been underestimated.

This nationwide propensity score–matched study demonstrated that perioperative TXA use was associated with a significant reduction in blood transfusion requirements after pelvic osteotomy in Japan, without an increased risk of postoperative complications. These findings corroborate prior evidence from Western populations and provide important real-world data supporting the routine use of TXA in pelvic osteotomy within the Japanese healthcare system.

Author Contribution

All authors are responsible for the work described in this paper. HT, KT, YM, KB, RK, HK, HK, HF, KF, KF and TA were involved in the study's conception, design, and planning. HT and YM were involved in the data analysis. HT, KT, YM, KB, RK, HK, HK, HF and TA interpreted the study results. All authors contributed to the critical review and approved the final manuscript.

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Table 1 Characteristics of patients after propensity score matching.
	TXA	Non TXA	SMD
n	3542	3542
Age	36.3 ±12.1	36.4 ± 12.6	0.005
Gender (%)
Men	319 (9.0)	289 (8.2)	0.003
Women	3223 (91.0)	3253 (91.8)
BMI	22.8 ± 4.1	22.8 ± 4.1	0.007
Operation type (%)
Transposition osteotomy	3271 (92.4)	3285 (92.7)	0.008
Pelvic Osteotomy	167 (4.7)	137 (3.9)
Shelf	104 (2.9)	120 (3.4)
CCI	0.12 ± 0.40	0.14 ± 0.45	0.041
post-operative Anticoagulate agent	2250 (63.5)	1987 (56.1)	0.152
Length of stay	42.6 ± 19.8	42.8 ± 20.6	0.009
Age, BMI, CCI, and length of stay shown as mean ± standard deviation
TXA; Tranexamic Acid, SMD; Standardized Mean Difference,
BMI; Body Mass Index, CCI; Charlson Comorbidity Index

Table 2 Association between use of TXA and blood transfusion and complications.
Complications	Total (n)		Univariate analysis			Multivariable analysis
		OR	95% CI	p-value	OR	95% CI	χ2 statics	p-value
Transfusion DAY 0	5423	0.647	0.579 - 0.723	< 0.05	0.619	0.552 - 0.693	68.71	< 0.05
Transfusion DAY 1	2553	0.515	0.467 - 0.569	< 0.05	0.523	0.472 - 0.579	156.4	< 0.05
Transfusion DAY 2	475	0.672	0.557 - 0.813	< 0.05	0.820	0.671 - 1.002	3.791	0.052
Infection	48	1.088	0.616 - 1.920	0.885	-	-	-	-
DVT	242	1.340	1.035 - 1.736	< 0.05	1.419	1.091 - 1.846	6.878	< 0.05
PE	14	1.000	0.350 - 2.854	1.000	-	-	-	-
Reoperation	14	2.504	0.785 - 7.992	0.179	2.269	0.696 - 7.393	2.018	0.155
P-values of < 0.05 are considered significant by the χ2 test
TXA; Tranexamic Acid, OR; Odds Ratio, CI; Confidence Interval, DVT; Deep Vein Thrombosis,PE; Pulmonary Embolism

Table 3 Ratio of autologous and allogeneic transfusion.
	TXA	Non TXA	p-value
Allogeneic Transfusion DAY 0	2554 (72.1)	2828 (79.8)	< 0.05
Autologous Transfusion DAY 0	43 (1.2)	40 (1.1)	0.825
Allogeneic Transfusion DAY 1	994 (28.1)	1527 (43.1)	< 0.05
Autologous Transfusion DAY 1	16 (0.5)	17 (0.5)	0.999
Allogeneic Transfusion DAY 2	188 (5.3)	270 (7.6)	< 0.05
Autologous Transfusion DAY 2	6 (0.2)	11 (0.3)	0.332
P-values of < 0.05 are considered significant by the χ2 test
TXA; Tranexamic Acid

No competing interests reported.

Tranexamic Acid Reduces Transfusion Requirements After Pelvic Osteotomy: A Nationwide Propensity Score–Matched Analysis

Status:

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Abstract

Figures

Introduction

Materials and Methods

Study design

Data selection

Statistical Analysis

Results

Discussion

Conclusion

Declarations

Author Contribution

References

Tables

Additional Declarations

Status:

Version 1