Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss After Total Hip Replacement
Condition: Blood Loss, Surgical
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares two oral medications (tranexamic acid and aminocaproic acid) as
      hemostatic agent administered in patients undergoing primary total hip replacement
    

Detailed description: 
      With the aging population, the incidence of joint osteoarthritis is rising. Total hip
      arthroplasty (THA) is one of the most common surgeries used for the treatment of end-stage
      degenerative hip disease, which is almost always accompanied by joint pain, deformity and
      motor dysfunction.

      Few articles have compared TXA and ε-ACA in joint arthroplasties. Whether ε-ACA has
      comparable hemostatic effects compared with TXA is unknown. A recent systematic review
      compared the effectiveness of TXA versus ε-ACA administered intravenously as a hemostatic
      agent in patients who had undergone a TKA and THR, and the results showed that the total
      blood loss was greater in the ε-ACA groups, but no significant differences between the two
      groups regarding transfusion rates were identified (Liu et al., 2018).

      Regarding oral administration, two clinical trials compared the use of oral TXA versus
      intravenous and topical in patients who had undergone THA, reaching the conclusion that if
      efficiency, safety, and cost are considered the main crucial parameters during the evaluation
      of TXA administration methods, oral TXA stands as an efficacious, safe, and low-cost method
      to reduce blood loss after THA compared with the IV and topical forms. Additionally,
      considering the ease of drug administration in the tablet form, oral TXA appears to represent
      a superior mode of administration than IV and topical TXA (Kayupov et al., 2017; Luo et al.,
      2018).

      The investigator's work team previously published a randomized controlled clinical trial in
      which it prospectively compared blood loss, transfusion rate and complications similar to
      this study but in total primary knee replacement, finding no differences with respect to any
      of the parameters studied except for the adverse effects, which were greater for the group
      that received tranexamic acid, this study was the first to compare the oral administration of
      these two medications in the field of orthopedics (Morales-Avalos et al., 2019) and the
      present protocol wants to do it now in the total primary hip replacement which is well known
      to be associated with greater blood loss than total knee replacement.

      HYPOTHESIS: There are no significant differences in blood loss (total blood loss, external
      blood loss, hidden blood loss, intraoperative blood loss and drainage output), transfusion
      index, complications and hemoglobin/hematocrit levels in patients undergoing total hip
      prostheses treated with tranexamic acid or aminocaproic acid orally.

      General objectives To compare the effect of oral aminocaproic acid as a hemostatic agent
      against oral tranexamic acid administered preoperatively and postoperatively in patients
      undergoing elective surgery of total hip replacement.

      Specific objectives

        1. Selection and randomization of patients.

        2. Performing total hip replacement surgery and administration of AAC or AXA according to
           randomization and the methodology established in this protocol

        3. Establishment of a protocol for the administration of aminocaproic acid orally for its
           use as a hemostatic agent in elective surgery of total hip replacement.

        4. Determination of total blood loss, external blood loss, hidden blood loss, transfusion
           index, decrease in hemoglobin/hematocrit levels, drainage volume, intrahospital stay,
           analogous visual scale and SF-12 scale between tranexamic acid and the aminocaproic
           acid, both orally, in each group in the pre-operatively, trans operatively and
           post-operatively established times and compare them statistically.

        5. Determine and record the possible complications and side effects observed with the use
           of both drugs included in the study.

        6. Determine the cost and monetary savings associated with the administration of each drug.

        7. Comparison and statistical analysis of the results between the study groups.
    

Intervention name(s): Aminocaproic Acid 1000Mg Tab; Tranexamic acid tablets
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of a total 6 g of aminocaproic acid to reduce blood loss; Oral administration of 3.9 g of tranexamic acid to reduce blood loss
Other intervention name(s): Oral administration of aminocaproic acid; Oral administration of tranexamic acid
Intervention MeSH terms: Tranexamic Acid; Aminocaproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two study groups will be generated, each consisting of 45 research subjects, randomly each recipient will receive 3 doses of one of the two study drugs (tranexamic acid or aminocaproic acid). The group to which the patient belongs will be assigned through a computer program, the patient will not know to which group he belongs or what medication he will receive. The patients will be extracted from the external traumatology clinic
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Total hip replacement; Oral tranexamic acid; Oral aminocaproic acid; Blood loss