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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
Sponsor:
Information provided by (Responsible Party):

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

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
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


Outcome Measures

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

Information from the National Library of Medicine

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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

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:

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