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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis; Blood Clot; Transfusion Related Complication; Blood Loss	Drug: Oral Tranexamic Acid; Drug: Oral Aminocaproic Acid	Phase 2

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	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.
Masking:	Single (Participant)
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 (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.
Primary Purpose:	Prevention
Official Title:	Comparative Study of the Efficiency of Oral Tranexamic Tcid vs. Oral Tminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement. A Prospective, Randomized, Double Blinded Controlled Clinical Trial.
Actual Study Start Date :	October 15, 2017
Estimated Primary Completion Date :	October 15, 2018
Estimated Study Completion Date :	December 15, 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Oral Tranexamic Acid; 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; Patients undergoing total knee replacement who will receive three doses of tranexamic acid administered orally (1 prior to surgery and 2 subsequent to surgery).
Experimental: Oral Aminocaproic Acid; 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; Patients undergoing total knee replacement who will receive three doses of aminocaproic acid administered orally (1 prior to surgery and 2 subsequent to surgery).; Other Name: Amicar

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in Hemoglobin level [ Time Frame: Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery ]
   Hemoglobin levels obtained in 3 samples taken at different times postsurgery

Secondary Outcome Measures :

1. Chage in Hematocrit level [ Time Frame: Hematocrit levels will be measured at 24, 48 and 72 hours postsurgery ]
   Hematocrit levels obtained in 3 samples taken at different times postsurgery
2. Drainage quantification [ Time Frame: Drainage quantification will be registered at 24 and 48 hours postsurgery ]
   Drainage will be quantified in ml at 2 different times postsurgery
3. Therapeutic effect on visual analog scale [ Time Frame: The third day postoperative ]
   The pain Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (scale of 10). It will be assessed as a numeric scale from 0 to 10.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Age over 18 years
2. Total replacement of the primary knee due to primary Osteoarthrosis
3. Two-compartment prosthesis
4. Unilateral procedure
5. Cemented 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 knee to intervene
4. Patients who have received aspirin, platelet or cumarinic 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. Total revision knee replacement
8. Total replacement of tumoral knee
9. Total bilateral knee 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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Felix Vilchez-Cavazos, M.D PhD	+52 (81) 83476698	vilchez.doctor@gmail.com
Contact: Rodolfo Morales-Avalos, M.D	+52 8183507313	rodolfot59@hotmail.com

Locations

Mexico
Facultad de Medicina UANL	Recruiting
Monterrey, Nuevo Leon, Mexico, 1-4469
Contact: Felix Vilchez, MD, PHD fvc78@hotmail.com
Contact: Rodolfo Morales-Avalos, MD 005218115557776 rodolfot59@hotmail.com

Sponsors and Collaborators

Universidad Autonoma de Nuevo Leon

Investigators

Principal Investigator:	Felix Vilchez-Cavazos, MD PhD	UANL

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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.

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.

Churchill JL, Puca KE, Meyer E, Carleton M, Anderson MJ. Comparing ε-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.

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. Review.

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.

Camarasa MA, Ollé G, Serra-Prat M, Martín A, Sánchez M, Ricós P, Pérez 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. Epub 2006 Mar 10.

Ahlberg A. Diffusion of epsilon aminocaproic acid to the joints. Proc Soc Exp Biol Med. 1970 Sep;134(4):988-9.

Responsible Party:	FELIX VILCHEZ CAVAZOS, Professor of Orthopedics and Traumatology, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier:	NCT03365999 History of Changes
Other Study ID Numbers:	OR17-00014
First Posted:	December 8, 2017
Last Update Posted:	December 8, 2017
Last Verified:	December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Sharing information has not been discussed with the ethics committee, it is necessary to define the need to share information relative to patients in order to perform and establish specific actions.

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		Yes

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Hemorrhage; Thrombosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Embolism and Thrombosis	Vascular Diseases; Cardiovascular Diseases; Tranexamic Acid; Aminocaproic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants