Distal femur fractures constitute a significant portion of lower-extremity trauma, often resulting from high-impact injuries such as motor vehicle accidents or falls in the elderly. Surgical management via internal fixation is the standard of care; Nevertheless, significant blood loss is linked to these treatments, frequently necessitating allogeneic transfusions. The risks of transfusion—immunologic reactions, infection, increased costs, and prolonged hospitalization—underscore the need for effective perioperative blood-conservation strategies.

By blocking plasminogen activation and halting fibrin breakdown, the synthetic lysine analogue (TXA) has an antifibrinolytic action. Numerous surgical specialties, most notably trauma and orthopaedic settings, have shown their effectiveness in lowering perioperative bleeding. TXA considerably lowers surgical and total blood loss and improves postoperative haemoglobin and haematocrit levels, according to a meta-analysis of randomized controlled trials for intertrochanteric fractures [1]. However, it had no discernible effect on transfusion rates or thromboembolic risk. In support of this, a more recent meta-analysis that included older patients with intramedullary fixation-treated intertrochanteric fractures also found positive results for TXA, confirming its haemostatic advantages and safety [2].

Beyond hip-related injuries, TXA has been evaluated in broader contexts of femoral fracture surgery. A systematic review concluded that TXA usage in femoral fracture fixation is associated with reduced perioperative bleeding without compromising thromboembolic safety [3]. Similarly, a single-blind randomized controlled trial in intertrochanteric fracture surgery found TXA to be both efficacious and safe in blood loss reduction [4]. A growing body of contemporary studies continues to affirm these findings, bolstering the evidence base for TXA in orthopaedic trauma [5,6].

Despite robust data in hip and intertrochanteric fractures, evidence for TXA use specifically in the context of distal femur fractures remains limited, particularly regarding internal fixation procedures. Distinct anatomical and vascular characteristics of the distal femur may influence bleeding patterns and antifibrinolytic efficacy differently compared to proximal femur sites. Accordingly, there is a pertinent need to investigate the role of TXA in this specific setting to determine whether the promising results observed in proximal fractures extend to distal femur internal fixation.

In order to close this gap, the current study will assess the safety and effectiveness of TXA in lowering perioperative blood loss in patients having distal femur fractures fixed internally. We hypothesize that TXA administration will lead to significantly lower intraoperative and postoperative bleeding, reduced haemoglobin decrement, and fewer transfusions, without increasing the risk of thromboembolic complications.

Study Design

This research was conducted as a prospective cohort study.

Study Setting

The study was carried out at Baba Saheb Ambedkar (BSA) Medical College & Hospital, New Delhi, a tertiary care centre with specialized orthopaedic surgical services. The study duration was six months.

Participants

Thirty patients in all were receiving internal fixation for fractures of the distal femur. Every participant fulfilled the qualifying requirements and was admitted to the orthopaedic department throughout the study period. Before participation, each patient provided written informed consent.

Inclusion Criteria

• Patients who are at least eighteen years old.
• Individuals who need internal fixation due to distal femur fractures.
• Individuals who are medically qualified for surgery while under general or spinal anaesthesia.
• A readiness to follow the study protocol and give informed consent.

Exclusion Criteria

• History of thromboembolic disorders (e.g., deep vein thrombosis, pulmonary embolism).
• Known hypersensitivity or contraindication to tranexamic acid.
• Coagulopathies or ongoing anticoagulant therapy.
• Severe renal or hepatic impairment.
• Pathological fractures or open fractures involving contamination.

Bias

All consecutively eligible patients during the study period were enrolled in order to reduce selection bias. Measurement bias was reduced by using standardized protocols for estimating blood loss. Data recording was performed by an independent observer blinded to the study hypothesis.

Data Collection

Demographic details, fracture type, preoperative haemoglobin, intraoperative estimated blood loss, postoperative drain output, postoperative haemoglobin levels, transfusion requirements, and any thromboembolic complications were recorded. All data were entered into a pre-designed case record form.

Procedure

All patients received standard preoperative preparation. The study group was administered intravenous (TXA) at a dose of 15 mg/kg 15–20 minutes before incision. Surgery was performed using standard internal fixation techniques under appropriate anaesthesia. Intraoperative blood loss was measured using suction collection and weighing of surgical sponges, while postoperative blood loss was estimated from drain output.

Statistical Analysis

Version 23.0 of the SPSS software (IBM Corp., Armonk, NY, USA) was used to analyse the data. The student’s t-test was used to compare continuous variables, which were reported as mean ± standard deviation (SD). Frequencies and percentages representing categorical variables were displayed, and the Chi-square test or Fisher's exact test, as applicable, was used for analysis. P-values less than 0.05 were regarded as statistically significant.

The study included 30 patients who were having internal fixation for fractures of the distal femur. The participants' ages ranged from 21 to 70 years old, with a mean age of 45.6 ± 12.3 years. Twelve females (40%) and eighteen males (60%) were present. Road traffic accidents accounted for 70% of all injury mechanisms, with falls from heights coming in second (30%).

Table 1. Baseline Demographic and Clinical Characteristics

This table shows that the study population was predominantly middle-aged, with a slightly higher proportion of males. Most patients sustained fractures from road traffic accidents, and preoperative haemoglobin levels were relatively well preserved.

Intraoperative Blood Loss

The mean intraoperative blood loss among patients receiving TXA was 450.3 ± 78.2 mL, which was significantly lower than the expected historical control mean of 650.5 ± 85.6 mL (p < 0.001).

Table 2. Intraoperative and Postoperative Blood Loss

*Student’s t-test compared with historical controls (without tranexamic acid). p < 0.05 is significant.
When compared to the usual blood loss values from prior institutional data, the administration of TXA led to a considerable decrease in both intraoperative and postoperative blood loss.

Change in Haemoglobin and Transfusion Requirement

The mean fall in haemoglobin from preoperative to postoperative Day 1 was 1.2 ± 0.3 g/dL. Only 2 patients (6.7%) required blood transfusion, compared to an institutional transfusion rate of approximately 30% in similar cases without TXA (p = 0.04).

Table 3. Haemoglobin Change and Transfusion Data

                                        *Significant at p < 0.05.

The lower mean haemoglobin reduction indicates reduced perioperative blood loss, and the low transfusion rate emphasizes the therapeutic advantage of TXA.

Complications

There were no reports of pulmonary embolism, deep vein thrombosis, or other thromboembolic events during the hospital stay or the one-month follow-up. Minor complications included mild postoperative swelling in 4 patients (13.3%), which resolved with conservative management.

Table 4. Postoperative Complications

(TXA) was not associated with any major thromboembolic events in this study, supporting its safety profile

This cohort research assessed 30 patients who were receiving internal fixation for distal femur fractures. The participants' average age was 45.6 years, and 60% of them were men. Seventy percent of injuries were caused by road accidents, with fall from heights coming in second at thirty percent. Baseline preoperative haemoglobin levels were comparable across participants, with a mean of 12.8 g/dL. Most patients were classified as ASA grade I or II, indicating relatively low perioperative risk.

The use of TXA led to a significant decrease in blood loss during surgery. The average blood loss throughout surgery was 570.9 mL, comprising a mean intraoperative blood loss of 450.3 mL and a mean postoperative drain output of 120.6 mL. When compared with historical institutional data for similar cases without tranexamic acid, this reduction was statistically significant (p < 0.001), underscoring the drug’s efficacy in minimizing surgical bleeding.

A corresponding benefit was observed in postoperative haemoglobin preservation. The mean haemoglobin drop from preoperative levels to the first postoperative day was only 1.2 g/dL, significantly lower than typical declines reported without (TXA) administration (p = 0.002). This translated into a lower blood transfusion requirement, with only 2 patients (6.7%) needing transfusion during their hospital stay, compared to an estimated 30% in historical controls (p = 0.04). This reduction not only decreases transfusion-associated risks but also has potential cost-saving implications.

No thromboembolic events, such as pulmonary embolism or deep vein thrombosis, were found during hospitalization or the one-month follow-up, according to the safety analysis. Minor complications were limited to mild postoperative swelling in 13.3% of patients and one case of superficial wound infection, both of which resolved with conservative measures. These results are consistent with the increasing amount of data demonstrating that, when utilized with the right patient selection, TXA is a safe adjunct in orthopaedic surgery.

All things considered, the findings show that (TXA) considerably lowers perioperative blood loss and transfusion requirements without raising the possibility of serious side effects. Its use in internal fixation of distal femur fractures appears to be both effective and safe, making it a valuable addition to perioperative blood management strategies in orthopaedic trauma surgery.

The use of TXA to lessen perioperative blood loss during orthopaedic fracture procedures, especially femur fractures, has been supported by recent research since 2018. Without worsening thromboembolic consequences, TXA administration dramatically decreased intraoperative blood loss, postoperative haemoglobin decline, and the requirement for allogeneic blood transfusion in a cohort analysis of patients having proximal femur fracture repair [7]. Similarly, a large-scale analysis confirmed these findings, demonstrating that TXA markedly lowered perioperative blood loss and transfusion rates in femur fracture surgeries, with no statistically significant increase in adverse events [8]. Comparative studies comparing topical and intravenous TXA use in hip and femur fracture procedures revealed that both techniques were equally successful in minimizing blood loss and the need for transfusions. Both routes are safe choices for perioperative blood conservation in fracture surgery, as neither was linked to increased risks of pulmonary embolism or deep vein thrombosis [9]. Intravenous TXA has been demonstrated to significantly reduce transfusion need and overall blood loss, including hidden blood loss, in elderly patients undergoing proximal femoral nail anti-rotation fixation. Crucially, these advantages were attained without increasing the frequency of thromboembolic incidents, highlighting TXA's safety record even in high-risk groups [10].

With no discernible rise in serious consequences, TXA efficiently lowers perioperative blood loss and transfusion needs in internal fixation of distal femur fractures, making it a useful and safe addition to surgical blood management.

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