Clinical Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery.
Condition: Tranexamic Acid (TXA); Prospective Study; Evidence-based Medicine; Randomized Controlled Trial
Study type: Interventional
Phase: Phase 4

Summary: 
      Study design: Randomized control trial Purpose: Evaluate the efficacy of oral administration
      of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction.

      Methods. A total of 60 patients undergoing major surgery of the spine, were randomly assigned
      into 2 groups. Group 1 was assigned as the control group and the other one included oral
      administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included
      intraoperative blood loss, postoperative blood loss, hematological parameters, blood
      transfusion needed, and surgical complications.
    

Detailed description: 
      The study design is a prospective randomized control trial done in a single institution from
      2021 to 2022. Approval from the institutional ethics committee was obtained for the study
      (number 04/21). Major surgery was defined as "surgeries involving the intervention of more
      than 4 levels of the thoracolumbar spine, and with a diagnosis of failed back surgery or,
      deformities in the spine". Patients excluded were those with low preoperative hemogram values
      (Hb <10mg/dL, low platelet counts (<100 x 109/L), bleeding disorders, coagulopathies, intake
      of contraceptives or anticoagulant medication, active thromboembolic disease (deep venous
      thromboembolism, chronic venous insufficiency, chronic thromboembolism), fibrinolytic
      disorders secondary to consumption coagulopathy, history of thromboembolic or coronary
      disease, history of seizure, liver failure, dyslipidemia, congenital coagulopathies (Von
      Willebrand Disease, Hemophilia A and B), acquired coagulopathy (Vitamin K deficiency,
      disseminated intravascular coagulation) and, thrombocytopenic purpura. Patients in whom
      postsurgical hemoglobin was not available, or patients who accidentally removed the drain or
      had leaks were eliminated from the study.

      General anesthesia was given for all the procedures and surgery was performed by two seniors'
      surgeons with over 27 years of experience in spine surgery, standard posterior approach was
      utilized in all cases, and all the cases were treated with pedicle screw fixation, at least
      one osteotomy and posterolateral or interbody fusion were performed in all the cases. All
      cases have been randomly divided into 2 groups.

      Interventions:

        1. Control group (n=30 cases): 100ml of water, and 3 tablets of placebo pills were
           administered 2 hours prior to surgery.

        2. PO TXA group (n=30 cases): Single dose of 1950 mg (3 tablets of 650 mg) was administered
           orally 2 hours before the surgical incision. The dose was administered by the nurse on
           duty who provided 100ml of water to swallow the pills.

      For both groups estimation of intraoperative bleeding was calculated by the anesthesiologist
      at the end of the surgery, anesthesiologist and surgeons in charge were blinded to the
      patient group, the need for transfusion during surgery and the amount of volume to be
      transfused was determined by the anesthesiologist. A suction drain was placed deep into the
      fascia before closure; the amount of total drainage at 36 hours was recorded. The Suction
      drain was constantly kept in suction mode, and it was removed when the output was less than
      100ml/24-hour period after postoperative day 1.

      Post-operatory transfusion (within the first 48 hours after surgery) was carried out in
      patients with hemoglobin <8mg/dL and for patients with clinical symptoms of anemia such as
      hypotension and tachycardia.

      Clinical data include age, height, weight, BMI, operative time, hemoglobin levels
      preoperatively and 24 hours postoperatively, number of spine levels operated, the volume of
      blood loss, calculated as intraoperative blood loss plus drainage collection total bleeding,
      number of transfusions received (units of transfusions received in the trans operative and
      postoperative period), length of stay and, the complication was also analyzed.

      Statistical Analysis The qualitative data were presented as numbers and percentages.
      Kolmogorov-Smirnov test determined normality of the data. The parametric quantitate data were
      presented as mean and standard deviation. Comparison between groups was analyzed by using the
      x2 test or Fisher exact test for qualitative data, and the unparaided t-test for quantitative
      data. A logistic regression model that included the variables use of oral TXA, sex, BMI, age,
      number of levels operated, complication, and time of surgery (mean 230min) was performed.

      A multivariate forward stepwise logistic regression model was then used to measure the
      adjusted association of these variables with intraoperative transfusion, with significance
      set at p<0.05. Data was analyzed using SPSS version 24.0 (IBM COrp, Armonk, NY).
    

Intervention name(s): Tranexamic Acid Oral Product; Placebo pills
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 1950 mg (3 tablets of 650 mg) was administered orally 2 hours before the surgical incision.; Single dose of 3 standard placebo pills administered orally 2 hours before the surgical incision.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 randomized groups
Masking: Single (Participant)
Primary purpose: Prevention