1.
Tranexamic Acid in Hip Reconstructions in Children with Cerebral Palsy: A Double-Blind Randomized Controlled Clinical Trial
Zuccon, A., Rogério Cardozo Kanaji, P., Serafini Barcellos, D., Zabulon, S., de Oliveira Saraiva, A., Yoshi de Freitas, T. A.
Children (Basel, Switzerland). 2023;10(12)
Abstract
Surgical treatment is indicated for hip dislocation in patients with cerebral palsy (CP), but it requires care due to the state of nutrition and associated clinical comorbidities. The use of resources that minimize blood loss and the need for blood transfusions are essential to avoid complications. Tranexamic acid (TXA) has been highlighted for orthopedic surgeries to control intraoperative bleeding; however, there is a lack of large studies for its use in hip surgeries in patients with CP. This study aims to evaluate the efficacy and safety of tranexamic acid to reduce bleeding in pediatric patients with cerebral palsy undergoing surgical treatment for hip instability. A sample of 31 patients with CP who underwent surgical treatment for hip dislocation (hip adductor stretching, varization osteotomy of the proximal femur and acetabuloplasty using the Dega technique) was randomly divided into groups: control (n = 10) and TXA (n = 21). Preoperative and 24 h hemoglobin concentrations, the length of hospital stay (LHS), and intraoperative bleeding (IB) were analyzed. TXA significantly reduced the IB (p = 0.02). The variance in hemoglobin concentration was lower for the TXA group, but without statistical significance (p = 0.06). There was no difference in LHS. Also, no statistical difference was observed for the number of transfusions (p = 0.08). The findings provide evidence of the effectiveness of TXA in decreasing intraoperative bleeding and its safety for use in pediatric patients with cerebral palsy.
2.
Perioperative blood loss reduction using a sterile exsanguination tourniquet for orthopedic femoral-related surgeries in children: a randomized controlled study
Rattanathanya, T., Adulkasem, N., Wongcharoenwatana, J., Ariyawatkul, T., Chotigavanichaya, C., Eamsobhana, P.
Journal of orthopaedic surgery and research. 2023;18(1):580
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Abstract
OBJECTIVES The sterile exsanguination tourniquet (SET) could be an alternative for providing bloodless surgeries in orthopedic femoral-related surgeries in pediatric patients where the standard pneumatic tourniquet would not be feasible. This randomized-controlled study aimed to evaluate the efficacy of SET in decreasing total perioperative blood loss and blood transfusion. METHODS We conducted an unplanned interim analysis of data from a randomized-controlled trial. At the time of the analysis, 31 pediatric patients had been randomly assigned to undergo surgery with the SET application (the SET group, 15 patients) and without the SET application (the control group, 16 patients). An intention-to-treat analysis was performed to evaluate the total perioperative blood loss, postoperative blood transfusion, estimated intraoperative blood loss, total drainage volume, postoperative hemoglobin level, and operative time according to the significance level adjusted for multiplicity (p < 0.029). RESULTS There was a borderline statistically significant lower body weight-adjusted TBL in the SET group (SET = 14.1 (7.7, 16.9) ml/kg vs. control 18.3 (14.8, 37.2) ml/kg, p-value = 0.027). The body weight-adjusted transfusion volume was statistically significantly greater in the control group (SET = 0.0 (0.0, 0.0) ml/kg vs. control = 2.1 (0.0, 9.7) ml/kg, p = 0.017). Body weight-adjusted estimated intraoperative blood loss was significantly lower in the SET group (SET = 0.8 (0.2, 3.5) ml/kg vs. control = 5.6 (3.4, 21.5) ml/kg, p < 0.001). In addition, the operative time was lower in the SET group with borderline statistical significance (SET = 105 (85.0, 125.0) vs. control = 130 (101.3, 167.5), p = 0.039). CONCLUSION Utilization of a sterile exsanguination tourniquet (SET) significantly reduced an estimated intraoperative blood loss while preventing the need for blood transfusion after pediatric orthopedic femoral-related surgeries. Trial registration TCTR20220412003.
PICO Summary
Population
Paediatric patients aged 3 to 18 undergoing elective femoral-related surgery (n= 31).
Intervention
Sterile exsanguination tourniquet (SET), (SET group, n= 15).
Comparison
No SET (Control group, n= 16).
Outcome
The primary outcomes were perioperative total blood loss (TBL) and transfusion rate at 72 hours after surgery. There was a borderline statistically significant lower body weight-adjusted TBL in the SET group (SET= 14.1 (7.7, 16.9) ml/kg vs. control 18.3 (14.8, 37.2) ml/kg). The body weight-adjusted transfusion volume was statistically significantly greater in the control group (SET= 0.0 (0.0, 0.0) ml/kg vs. control= 2.1 (0.0, 9.7) ml/kg). Body weight-adjusted estimated intraoperative blood loss was significantly lower in the SET group (SET= 0.8 (0.2, 3.5) ml/kg vs. control= 5.6 (3.4, 21.5) ml/kg). The operative time was lower in the SET group with borderline statistical significance (SET= 105 (85.0, 125.0) vs. control= 130 (101.3, 167.5)).
3.
Effect of tranexamic acid on intraoperative blood loss in pediatric osteotomies around the hip: Study protocol for a double-blind randomized placebo-controlled trial
van Kouswijk, H. W., Tolk, J. J., van Bommel, C. P., Reijman, M., Kempink, D. R., de Witte, P. B.
Journal of children's orthopaedics. 2023;17(5):404-410
Abstract
BACKGROUND Proximal femoral and/or pelvic osteotomies (PFPOs) can be indicated for a multitude of hip pathologies in (often asymptomatic) children, to prevent future hip problems. These procedures can result in significant blood loss. Tranexamic acid (TXA) is an antifibrinolytic agent routinely administered in adult trauma and joint reconstruction surgery to reduce blood loss. TXA is also registered for use in children and reported safe and beneficial for pediatric trauma, cardiac, and spinal surgery. However, for pediatric orthopedics, particularly for PFPOs, the available evidence is limited. Therefore, the current trial will investigate the potential reducing effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. METHODS In this single-center, double-blind, randomized placebo-controlled trial, we aim to include 180 participants aged from 1 to 18 years undergoing PFPOs for any indication at our institution. Participants will be randomized to receive either TXA or placebo (saline) during anesthetic induction. The primary outcome is intraoperative estimated blood loss (mL/kg), which is determined gravimetrically. Secondary outcomes include the percentage of patients with excessive blood loss (>20 mL/kg), procedure time and hospital stay, and postoperative hemoglobin level changes. DISCUSSION This will be the first prospective study investigating the effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. Its results will help to determine whether it would be advisable to adopt preoperative TXA as a standard medication to minimize blood loss and prevent complications in this vulnerable population. TRIAL REGISTRATION EudraCT: 2022-002384-30. Prospectively registered on September 26, 2022.