Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss After Total Hip Replacement

Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss, Transfusion Index and Complications After Total Hip Replacement. A Prospective, Randomized, Double Blind Clinical Trial

Sponsors

Lead Sponsor: Carlos A Acosta-Olivo

Source Universidad Autonoma de Nuevo Leon
Brief 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.

Overall Status Recruiting
Start Date 2020-02-06
Completion Date 2021-03-30
Primary Completion Date 2021-02-28
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Total blood loss (TBL) The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours
External blood loss (EBL) On the second postoperative day (48 hours), when removing the surgical drainage.]
Hidden blood loss (HBL) The third day postoperative
Secondary Outcome
Measure Time Frame
Change in hematocrit level Hematocrit levels will be measured at 24, 48 and 72 hours postsurgery
Drainage quantification Drainage quantification will be registered at 24 and 48 hours postsurgery
Therapeutic effect on visual analog scale Pain will be measured at 24, 48 and 72 hours postsurgery
Change in Hemoglobin level Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery
Rate of complications at 24, 48 and 72 hours, 7 days, 4 and 6 weeks
Rate of transfusion at 24, 48 and 72 hours, 7 days, 4 and 6 weeks
Rate of intraoperative blood loss Immediately after the end of the surgery
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Aminocaproic Acid 1000Mg Tab

Description: Oral administration of a total 6 g of aminocaproic acid to reduce blood loss

Arm Group Label: Aminocaproic acid

Other Name: Oral administration of aminocaproic acid

Intervention Type: Drug

Intervention Name: Tranexamic acid tablets

Description: Oral administration of 3.9 g of tranexamic acid to reduce blood loss

Arm Group Label: Tranexamic acid

Other Name: Oral administration of tranexamic acid

Eligibility

Criteria:

Inclusion Criteria: 1. Age over 18 years 2. Total replacement of the primary hip due to: 1) Primary Coxarthrosis, 2) Avascular hip necrosis, 3) Transcervical fracture 3. Unilateral procedure 4. Press-fit prosthesis 5. Without the use of cement for the placement of the prosthesis 6. Desire to participate voluntarily in the study and signature of informed consent 7. Pre-operative assessment with result between ASA I, ASA II or ASA III performed and annexed in the clinical file either by the Department of Internal Medicine, Cardiology or Anesthesiology of our hospital. 8. Possibility for oral administration of the drug. Exclusion Criteria: 1. History of thrombotic or embolic event in the last 6 months 2. Clinical history of coagulopathy 3. Previous surgeries in the hip to intervene 4. Patients who have received aspirin, platelet or coumarinic antiplatelet agents in the week prior to surgery or NSAIDs two days prior to surgery. 5. History of myocardial infarction, arteriopathy or unstable angina in the 12 months prior to surgery. 6. Those patients whose preoperative assessment corresponds to an ASA IV or the procedure is contraindicated in its preoperative assessment. 7. Revision hip replacement 8. Tumoral hip replacement 9. Bilateral hip replacement 10. Cognitive deficit 11. Patients who meet the inclusion criteria but do not wish to participate in the study 12. Patients with a diagnosis of Terminal Chronic Kidney Disease or with a serum creatinine higher than 1.47 mg / dl in the preoperative laboratories. 13. Patients with inability to ingest the drug orally. 14. Patients who are pregnant or breast-feeding or who are taking oral contraceptives. 15. Seizure history 16. Hypersensitivity to the active substance or to any of the excipients

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Carlos Acosta-Olivo, PhD Study Chair Universidad Autonoma de Nuevo Leon
Overall Contact

Last Name: Carlos Acosta-Olivo, PhD

Phone: +528183476698

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Universidad Autonoma de Nuevo Leon Carlos Acosta-Olivo, PhD [email protected]
Location Countries

Mexico

Verification Date

2021-01-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Universidad Autonoma de Nuevo Leon

Investigator Full Name: Carlos A Acosta-Olivo

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tranexamic acid

Type: Active Comparator

Description: Will be administered orally three times (administering 2 tablets each time). In the case of tranexamic acid are 650 mg each. The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water. For tranexamic acid a total dose of 3.9 grams (6 tablets) divided between the 3 administrations (1.3 grams each, ie 2 tablets of 650 mg) will be administered.

Label: Aminocaproic acid

Type: Experimental

Description: Will be administered orally three times (administering 2 tablets each time). In the case of aminocaproic tablets are 1000 mg each.The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water. For the aminocaproic acid, a total dose of 6 grams (6 tablets) divided between the 3 administrations (2 gram each, ie 2 tablets of 1000 mg) will be administered.

Patient Data No
Study Design Info

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

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Masking Description: Prior to being included in the study, the patient will be mentioned the times when he will receive the medication as well as the dosage of administration. The patient will not know what medication is being administered to him / her. The pills will be given to the patient in a medicine cup without access to any information legend. In the same way, the medication will be administered by a doctor outside the research protocol and will not participate in any other phase of the study so that no member of the research team will know what medication was administered.

Source: ClinicalTrials.gov

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