Intravenous and Oral Tranexamic Acid Are Equivalent at Reducing Blood Loss in Thoracolumbar Spinal Fusion

A Prospective Randomized Trial

Charles C. Yu, MD; Omar Kadri, MD; Allen Kadado, MD; Morenikeji Buraimoh, MD; Jacob Pawloski, BS; Stephen Bartol, MD; Gregory Graziano, MD

Disclosures

Spine. 2019;44(11):755-761. 

In This Article

Results

During the period of study enrollment from February and December 2017, 100 patients were scheduled for elective thoracolumbar fusion surgery. Seventeen patients were ineligible due to meeting exclusion criteria, refusal to participate or missing pertinent lab values (Figure 1). Among the 83 enrolled study participants who underwent randomization, 43 had IV TXA and 40 had PO TXA. No patient was lost or excluded during the follow-up period. Two orthopedic spine surgeons performed the operations: Gregory Graziano performed majority of the surgeries (89% of total, 93% and 85% for IV and PO, respectively), and Stephen Bartol performed the rest. Standard posterior approach was utilized in all cases except for one DLIF that was performed in the PO group.

Figure 1.

Consolidated standards of reporting trials (CONSORT) flow diagram of the study. TXA indicates tranexamic acid.

The average age of an enrolled patient was 63 ± 13 years (mean ± SD). There were 49 females and 34 males. There were no statistical differences in the patient characteristics and preoperative measurements pertaining to age, sex, weight, height, ASA, estimated blood volume, preoperative anticoagulant use, and pertinent preoperative laboratory values including hemoglobin, hematocrit, international normalized ratio, and creatinine (Table 1). BMI was higher in the PO TXA group (32.1 ± 5.8 kg/m2) than in the IV TXA group (28.5 ± 5.7 kg/m2) (P = 0.006). Furthermore, preoperative platelet count was higher in PO group (240 ± 53 × 103/mm3) than in IV group (205 ± 61 × 103/mm3) (P = 0.008). Revision cases comprised of 59% of the total sample (65% and 53% for IV and PO, respectively). A single level pedicle subtraction osteotomy (PSO) was performed for 12 patients (six in each group) by Gregory Graziano. TLIF was performed for 22 patients (7 and 15 for IV and PO, respectively), and chi-square analysis showed a statistically significant difference (P = 0.03). Intraoperative measures between the treatment groups demonstrated no statistical difference in anesthesia time, surgery time, EBL, IVF, percentage of patients receiving cell saver, and percentage of patients receiving blood transfusion. Overall, the patients within the two treatment groups were considered similar in regard to the measured independent variables (Table 2).

Primary Outcome Measure

The reduction in Hgb was statistically equivalent between IV and PO TXA (Table 3). The reduction in hemoglobin for the IV TXA group was 3.36 ± 1.82 g/dL while the drop in Hgb for the PO TXA group was 3.43 ± 1.75 g/dL (P = 0.01, equivalent).

Secondary Outcome Measures

The calculated blood loss between the IV and PO TXA groups was equivalent (Table 3). On average, the volume of blood loss for the IV and PO TXA groups was 1235 ± 672 mL and 1312 ± 748 mL (P = 0.02, equivalent), respectively. Hematocrit drop between IV and PO TXA groups was also equivalent (Table 3). The change in hematocrit for IV and PO groups was calculated to be 10.0 ± 5.4 and 10.2 ± 5.4 (P = 0.009, equivalent), respectively. Postoperative rate of transfusion, drain output, length of hospital stay, and complications demonstrated no statistical difference between IV and PO TXA groups (Table 3). Total drain output for IV and PO TXA groups was similar at 620 ± 499 mL and 655 ± 607 mL (P = 0.77), respectively. Eight patients (19%) in IV TXA group received a transfusion compared with five patients in PO TXA group (13%) (P = 0.44). One patient (2% and 3% in IV and PO, respectively) in each group experienced a deep venous thrombosis/pulmonary embolism (P = 0.96). Three patients (7%) in IV TXA group had superficial surgical site infection (SSSI), and two patients (5%) had deep surgical site infection (DSSI) (P = 0.71). Length of hospital stay was similar between IV and PO groups, 4.5 ± 2.8 days and 4.1 ± 3.4 days (P = 0.64).

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....