Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.

NCT03365999 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: OR17-00014
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing total knee replacement.

Conditions

Knee Osteoarthritis; Blood Clot; Transfusion Related Complication; Blood Loss

Outcome Measures

Primary Outcomes (3)

• Total blood loss (TBL)

  Total blood loss 72 hours after surgery,The Gross and Nadler formula was used to calculate TBL. TBL = patient's blood volume (PBV) x (Hctpre - Hctpost)/Hctave (Hctpre = the initial pre-operative Hct level, Hctpost = the Hct on the morning of POD3). PBV = k1 x height (m) + k2 x weight (kg) + k3 (k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men; and k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833 for women, Hctave = the average of the Hctpre and Hctpost)

  The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours.

• External blood loss (EBL)

  External blood loss (EBL) was estimated by adding the intraoperative bleeding and the blood in the drain collectors upon removal after 48 hours

  On the second postoperative day (48 hours), when removing the surgical drainage.

• Hidden blood loss (HBL)

  was defined as Total blood loss minus External blood loss

  The third day postoperative

Secondary Outcomes (7)

• Chage 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

  The third day postoperative

• Change in Hemoglobin level

  Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery

• Complications

  at 24, 48 and 72 hours, 7 days, 4 and 6 weeks.

Study Arms (2)

Oral Tranexamic Acid

ACTIVE COMPARATOR

Tranexamic acid will be administered orally three times (administering 2 tablets each time). In the case of tranexamic acid tablets 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 the 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.

Drug: Oral Tranexamic Acid

Oral Aminocaproic Acid

EXPERIMENTAL

Aminocaproic acid will be administered orally three times (administering 2 tablets each time). In the case of aminocaproic acid tablets are 500 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 3 grams (6 tablets) divided between the 3 administrations (1 gram each, ie 2 tablets of 500 mg) will be administered.

Drug: Oral Aminocaproic Acid

Interventions

Oral Tranexamic Acid DRUG

Patients undergoing total knee replacement who will receive three doses of tranexamic acid administered orally (1 prior to surgery and 2 subsequent to surgery).

Oral Tranexamic Acid

Oral Aminocaproic Acid DRUG

Patients undergoing total knee replacement who will receive three doses of aminocaproic acid administered orally (1 prior to surgery and 2 subsequent to surgery).

Also known as: Amicar

Oral Aminocaproic Acid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Total replacement of the primary knee due to primary Osteoarthrosis
• Two-compartment prosthesis
• Unilateral procedure
• Cemented prosthesis
• Desire to participate voluntarily in the study and signature of informed consent
• 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.
• Possibility for oral administration of the drug.

You may not qualify if:

• History of thrombotic or embolic event in the last 6 months
• Clinical history of coagulopathy
• Previous surgeries in the knee to intervene
• Patients who have received aspirin, platelet or cumarinic antiplatelet agents in the week prior to surgery or NSAIDs two days prior to surgery.
• History of myocardial infarction, arteriopathy or unstable angina in the 12 months prior to surgery.
• Those patients whose preoperative assessment corresponds to an ASA IV or the procedure is contraindicated in its preoperative assessment.
• Total revision knee replacement
• Total replacement of tumoral knee
• Total bilateral knee replacement
• Cognitive deficit
• Patients with a diagnosis of Terminal Chronic Kidney Disease or with a serum creatinine higher than 1.47 mg / dl in the preoperative laboratories.
• Patients with inability to ingest the drug orally.
• Patients who are pregnant or breast-feeding or who are taking oral contraceptives.
• Seizure history
• Hypersensitivity to the active substance or to any of the excipients.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Facultad de Medicina UANL

Monterrey, Nuevo León, 1-4469, Mexico

Location

Related Publications (8)

• Boese CK, Centeno L, Walters RW. Blood Conservation Using Tranexamic Acid Is Not Superior to Epsilon-Aminocaproic Acid After Total Knee Arthroplasty. J Bone Joint Surg Am. 2017 Oct 4;99(19):1621-1628. doi: 10.2106/JBJS.16.00738.

  PMID: 28976426 RESULT

• Harper RA, Sucher MG, Giordani M, Nedopil AJ. Topically Applied Epsilon-Aminocaproic Acid Reduces Blood Loss and Length of Hospital Stay After Total Knee Arthroplasty. Orthopedics. 2017 Nov 1;40(6):e1044-e1049. doi: 10.3928/01477447-20170925-07. Epub 2017 Oct 3.

  PMID: 28968480 RESULT

• Hobbs JC, Welsby IJ, Green CL, Dhakal IB, Wellman SS. Epsilon Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Hip and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):55-60. doi: 10.1016/j.arth.2017.08.020. Epub 2017 Aug 24.

  PMID: 28939033 RESULT

• Churchill JL, Puca KE, Meyer E, Carleton M, Anderson MJ. Comparing epsilon-Aminocaproic Acid and Tranexamic Acid in Reducing Postoperative Transfusions in Total Knee Arthroplasty. J Knee Surg. 2017 Jun;30(5):460-466. doi: 10.1055/s-0036-1593362. Epub 2016 Oct 3.

  PMID: 27699724 RESULT

• Banerjee S, Issa K, Pivec R, McElroy MJ, Khanuja HS, Harwin SF, Mont MA. Intraoperative pharmacotherapeutic blood management strategies in total knee arthroplasty. J Knee Surg. 2013 Dec;26(6):379-85. doi: 10.1055/s-0033-1353992. Epub 2013 Aug 16.

  PMID: 23955184 RESULT

• Sepah YJ, Umer M, Ahmad T, Nasim F, Chaudhry MU, Umar M. Use of tranexamic acid is a cost effective method in preventing blood loss during and after total knee replacement. J Orthop Surg Res. 2011 May 21;6:22. doi: 10.1186/1749-799X-6-22.

  PMID: 21600028 RESULT

• Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, Perez A, Opisso L. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006 May;96(5):576-82. doi: 10.1093/bja/ael057. Epub 2006 Mar 10.

  PMID: 16531440 RESULT

• Ahlberg A. Diffusion of epsilon aminocaproic acid to the joints. Proc Soc Exp Biol Med. 1970 Sep;134(4):988-9. doi: 10.3181/00379727-134-34927. No abstract available.

  PMID: 4195730 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Thrombosis; Hemorrhage

Interventions

Tranexamic Acid; Aminocaproic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminocaproates; Caproates; Acids, Acyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Felix Vilchez-Cavazos, MD PhD

  UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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 (which is the same for each of the two medications). The patient will not know what medication is being administered to him / her. no time The pills will be given to you in a medicine cup without access to any information legend.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics and Traumatology

Model Details: Two study groups will be generated, each consisting of 40 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.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 8, 2017
• Study Start: October 15, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)