Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery

NCT03386656 | Completed Phase 3

• 1 other identifier: FPS-TRA-2017-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed with severe knee osteoarthritis who will undergo prosthetic knee surgery in terms of saving blood loss (estimated blood loss, decreased hemoglobin and Decrease in hematocrit).

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Saving blood loss in knee surgery

  Total blood loss greater than 245 ml

  24 hours post-intervention

Secondary Outcomes (2)

• Time post-intervention of functional recovery in study subjects

  Four weeks post-discharger

• Length of hospital stay in study subjects

  Four weeks post-discharger

Study Arms (2)

Amchafibrin

EXPERIMENTAL

Estimated total blood loss, measured using the formula described by Nadler. A difference in estimated blood loss greater than or equal to 245 ml will be considered clinically relevant.

Drug: Amchafibrin

Saline Solution 0,9%.

PLACEBO COMPARATOR

Comparator of tranexamic acid

Other: Saline Solution

Interventions

Amchafibrin DRUG

Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.

Amchafibrin

Saline Solution OTHER

Placebo

Also known as: Placebo

Saline Solution 0,9%.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes, in the age group: ≥18 and ≤80 years.
• Patients diagnosed with confirmation of severe knee osteoarthritis according to Kellgren criteria (equal or greater than 2) and EVA greater than 7, who will be subjected to knee arthroplasty surgery.
• Patients signing informed consent, agreeing to participate in the study.

You may not qualify if:

• Patients with concomitant cardiac disease: unstable angina pectoris, acute myocardial infarction, atrial fibrillation, flutter, history of sudden death, severe valve insufficiency.
• Patients with concomitant previous thromboembolic disease: Deep venous thrombosis, pulmonary thromboembolism, thrombotic arterial embolism, Ischemic Vascular Cerebral Stroke, fibrinolytic diseases after consumption coagulopathy.
• Hypersensitivity to tranexamic acid.
• Severe systemic disease: cardio-pulmonary, neurological, renal, infectious or any other type that may impede the development of the study or evaluation of the results.
• History of seizures.
• Patients with severe mental disorder (psychotic disorder, risk of autolysis, manic episode), dependence on toxic substances and / or some physical or psychological limitation to answer.
• Patients receiving oral anticoagulants.
• Patients in litigation for disability claim related or not with the disease.
• Patients who cannot make the necessary visits to carry out the study.
• Patients who refuse to participate or sign informed consent.
• Pregnant and lactating patient's period.

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead

Study Sites (1)

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: December 29, 2017
• Study Start: November 28, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 8, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

ES (1)