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

NCT04187014 | Completed Phase 2 DMC

• 1 other identifier: OR19-00003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Surgical

Keywords

Total hip replacement; Oral tranexamic acid; Oral aminocaproic acid; Blood loss

Outcome Measures

Primary Outcomes (3)

• Total blood loss (TBL)

  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)

  The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours

• External blood loss (EBL)

  External blood loss (EBL) was estimated by adding the intraoperative bleeding and the blood in the drain collectors upon removal after 48 hours

  On the second postoperative day (48 hours), when removing the surgical drainage.]

• Hidden blood loss (HBL)

  Defined as total blood loss minus external blood loss

  The third day postoperative

Secondary Outcomes (7)

• Change in hematocrit level

  Hematocrit levels will be measured at 24, 48 and 72 hours postsurgery

• Drainage quantification

  Drainage quantification will be registered at 24 and 48 hours postsurgery

• Therapeutic effect on visual analog scale

  Pain will be measured at 24, 48 and 72 hours postsurgery

• Change in Hemoglobin level

  Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery

• Rate of complications

  at 24, 48 and 72 hours, 7 days, 4 and 6 weeks

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

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

Aminocaproic acid

EXPERIMENTAL

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

Interventions

Aminocaproic Acid 1000Mg Tab DRUG

Oral administration of a total 6 g of aminocaproic acid to reduce blood loss

Also known as: Oral administration of aminocaproic acid

Aminocaproic acid

Tranexamic acid tablets DRUG

Oral administration of 3.9 g of tranexamic acid to reduce blood loss

Also known as: Oral administration of tranexamic acid

Tranexamic acid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Total replacement of the primary hip due to: 1) Primary Coxarthrosis, 2) Avascular hip necrosis, 3) Transcervical fracture
• Unilateral procedure
• Press-fit prosthesis
• Without the use of cement for the placement of the 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.

You may not qualify if:

• History of thrombotic or embolic event in the last 6 months
• Clinical history of coagulopathy
• Previous surgeries in the hip to intervene
• Patients who have received aspirin, platelet or coumarinic 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.
• Revision hip replacement
• Tumoral hip replacement
• Bilateral hip replacement
• Cognitive deficit
• 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

Sponsors & Collaborators

• Carlos A Acosta-Olivo: lead

Study Sites (1)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 66460, Mexico

Location

Related Publications (4)

• Kayupov E, Fillingham YA, Okroj K, Plummer DR, Moric M, Gerlinger TL, Della Valle CJ. Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 1;99(5):373-378. doi: 10.2106/JBJS.16.00188.

  PMID: 28244907 RESULT

• Luo ZY, Wang HY, Wang D, Zhou K, Pei FX, Zhou ZK. Oral vs Intravenous vs Topical Tranexamic Acid in Primary Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Study. J Arthroplasty. 2018 Mar;33(3):786-793. doi: 10.1016/j.arth.2017.09.062. Epub 2017 Oct 6.

  PMID: 29107495 RESULT

• Liu Q, Geng P, Shi L, Wang Q, Wang P. Tranexamic acid versus aminocaproic acid for blood management after total knee and total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Jun;54(Pt A):105-112. doi: 10.1016/j.ijsu.2018.04.042. Epub 2018 May 1.

  PMID: 29723672 RESULT

• Morales-Avalos R, Ramos-Morales T, Espinoza-Galindo AM, Garay-Mendoza D, Pena-Martinez VM, Marfil-Rivera LJ, Garza-Ocanas L, Acosta-Olivo C, Cerda-Barbosa JK, Valdes-Gonzalez NL, Vilchez-Cavazos F. First Comparative Study of the Effectiveness of the Use of Tranexamic Acid against epsilon-Aminocaproic Acid via the Oral Route for the Reduction of Postoperative Bleeding in TKA: A Clinical Trial. J Knee Surg. 2021 Mar;34(4):383-405. doi: 10.1055/s-0039-1696722. Epub 2019 Sep 6.

  PMID: 31491796 RESULT

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage

Interventions

Aminocaproic Acid; Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanecarboxylic Acids; Acids, Carbocyclic

Study Officials

• Carlos Acosta-Olivo, PhD

  Universidad Autonoma de Nuevo Leon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 5, 2019
• Study Start: February 6, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)