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
: December 8, 2017
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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 |

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 |

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).
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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
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- 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
- 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.

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

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
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 |
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 |
Principal Investigator: | Felix Vilchez-Cavazos, MD PhD | UANL |
Publications of Results:
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: | 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 |