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Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss After Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT04187014
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Brief Summary:
This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing primary total hip replacement

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Drug: Aminocaproic Acid 1000Mg Tab Drug: Tranexamic acid tablets Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two study groups will be generated, each consisting of 45 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: Double (Participant, Investigator)
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. The patient will not know what medication is being administered to him / her. The pills will be given to the patient in a medicine cup without access to any information legend. In the same way, the medication will be administered by a doctor outside the research protocol and will not participate in any other phase of the study so that no member of the research team will know what medication was administered.
Primary Purpose: Prevention
Official Title: Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss, Transfusion Index and Complications After Total Hip Replacement. A Prospective, Randomized, Double Blind Clinical Trial
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tranexamic acid

Will be administered orally three times (administering 2 tablets each time). In the case of tranexamic acid 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 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: Tranexamic acid tablets
Oral administration of 3.9 g of tranexamic acid to reduce blood loss
Other Name: Oral administration of tranexamic acid

Experimental: Aminocaproic acid

Will be administered orally three times (administering 2 tablets each time). In the case of aminocaproic tablets are 1000 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 6 grams (6 tablets) divided between the 3 administrations (2 gram each, ie 2 tablets of 1000 mg) will be administered.

Drug: Aminocaproic Acid 1000Mg Tab
Oral administration of a total 6 g of aminocaproic acid to reduce blood loss
Other Name: Oral administration of aminocaproic acid




Primary Outcome Measures :
  1. 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)

  2. 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

  3. Hidden blood loss (HBL) [ Time Frame: The third day postoperative ]
    Defined as total blood loss minus external blood loss


Secondary Outcome Measures :
  1. Change 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: Pain will be measured at 24, 48 and 72 hours postsurgery ]
    The 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.

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

  5. Rate of 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

  6. Rate of transfusion [ Time Frame: at 24, 48 and 72 hours, 7 days, 4 and 6 weeks ]
    Need to administer globular packages following the indications of transfusion haemoglobin (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 other causes). 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

  7. Rate of 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



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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:

  1. Age over 18 years
  2. Total replacement of the primary hip due to: 1) Primary Coxarthrosis, 2) Avascular hip necrosis, 3) Transcervical fracture
  3. Unilateral procedure
  4. Press-fit prosthesis
  5. Without the use of cement for the placement of the 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 hip to intervene
  4. Patients who have received aspirin, platelet or coumarinic 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. Revision hip replacement
  8. Tumoral hip replacement
  9. Bilateral hip 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

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): NCT04187014


Contacts
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Contact: Carlos Acosta-Olivo, PhD +528183476698 dr.carlosacosta@gmail.com
Contact: Rodolfo Morales-Avalos, MD rodolfot59@gmail.com

Locations
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Mexico
Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 66460
Contact: Carlos Acosta-Olivo, PhD       dr.carlosacosta@gmail.com   
Contact: Rodolfo Morales-Avalos, MD       rodolfot59@gmail.com   
Sponsors and Collaborators
Carlos A Acosta-Olivo
Investigators
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Study Chair: Carlos Acosta-Olivo, PhD Universidad Autonoma de Nuevo Leon

Publications of Results:
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Responsible Party: Carlos A Acosta-Olivo, Professor, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT04187014     History of Changes
Other Study ID Numbers: OR19-00003
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
Total hip replacement
Oral tranexamic acid
Oral aminocaproic acid
Blood loss
Additional relevant MeSH terms:
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Tranexamic Acid
Aminocaproic Acid
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants