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

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ClinicalTrials.gov Identifier: NCT03365999

Recruitment Status : Recruiting

First Posted : December 8, 2017

Last Update Posted : November 27, 2018

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Sponsor:

Information provided by (Responsible Party):

FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon

Study Description

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

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Study Design


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 :	December 15, 2018
Estimated Study Completion Date :	December 15, 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Osteoarthritis

MedlinePlus related topics: Bleeding Blood Transfusion and Donation Knee Replacement

Drug Information available for: Aminocaproic acid Tranexamic acid

U.S. FDA Resources

Arms and Interventions

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

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.

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

Primary Outcome Measures :

Total blood loss (TBL) [ Time Frame: The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours. ]
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)
External blood loss (EBL) [ Time Frame: On the second postoperative day (48 hours), when removing the surgical drainage. ]
External blood loss (EBL) was estimated by adding the intraoperative bleeding and the blood in the drain collectors upon removal after 48 hours
Hidden blood loss (HBL) [ Time Frame: The third day postoperative ]
was defined as Total blood loss minus External blood loss

Secondary Outcome Measures :

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
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
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.
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
Complications [ Time Frame: at 24, 48 and 72 hours, 7 days, 4 and 6 weeks. ]
Complications related to the surgery or to the administration of the study medication
Transfusion rate [ Time Frame: at 24, 48 and 72 hours, 7 days, 4 and 6 weeks. ]
Need to administer globular packages following the indications of transfusion haemaglobin (Hb) of 8 g/dl in patients free of cardiovascular disease and Hb of 9 g/dl in patients with established cardiovascular disease or cardiovascular risk factors with symptoms of anaemia (defined as bad mental status, palpitation, or shortness of breath not due to othercauses). Hb below 10 g/dl in patients with poor clinical tolerance of lower values was also an indication for transfusion. Symptoms of poor clinical tolerance of lower values were signs of hypoxia such as tachycardia, dyspnoea or syncope or drainage of more than 1 l of blood in the first 24 hours.
Intraoperative blood loss [ Time Frame: Immediately after the end of the surgery ]
Intra-operative blood loss was calculated using the difference between the weights of the used gauze and the original unused gauze (25 cm x 25 cm, monolayer, weight of 30 grams), in addition to the blood volume accumulated in suction bottles subtracting the volume of saline solution during the surgery

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 who meet the inclusion criteria but do not wish to participate in the study
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365999

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

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 Key Record Dates
Last Update Posted:	November 27, 2018
Last Verified:	November 2018
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

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