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

• Sponsor: Fundación Pública Andaluza Progreso y Salud (Other)
• Overall Status: Completed
• CT.gov ID: NCT03386656
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Amchafibrin; Other: Saline Solution	Phase 3

Detailed Description

Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. Tranexamic acid binds to plasminogen when it is transformed into plasmin. The activity of the tranexamic acid-plasmin complex on fibrin activity is less than the activity of free plasmin alone.

There are two methods of presentation: one, as an injectable solution; Two as a clear, colorless aqueous solution.

Tranexamic acid in Spain is approved for use in the prevention and treatment of bleeding due to general fibrinolysis. As for its specific indications the investigators find that it is used for the treatment of metrorrhagia, menorrhagia, gastrointestinal hemorrhage, urinary hemorrhagic disorders after prostate surgery, surgery of ears, nose, throat, gynecological, thoracic, abdominal or cardiovascular or to counter associated hemorrhages To the administration of a fibrinolytic drug.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery
• Actual Study Start Date: Nov 28, 2017
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amchafibrin 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; Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
Placebo Comparator: Saline Solution 0,9%. Comparator of tranexamic acid	Other: Saline Solution; Placebo; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Saving blood loss in knee surgery [24 hours post-intervention]

   Total blood loss greater than 245 ml

Secondary Outcome Measures

1. Time post-intervention of functional recovery in study subjects [Four weeks post-discharger]

2. Length of hospital stay in study subjects [Four weeks post-discharger]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Puerta del Mar	Cadiz		Spain	11009

Sponsors and Collaborators

• Fundación Pública Andaluza Progreso y Salud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundación Pública Andaluza Progreso y Salud
• ClinicalTrials.gov Identifier: NCT03386656
• Other Study ID Numbers: FPS-TRA-2017-02
• First Posted: Dec 29, 2017
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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.: Yes
• Keywords provided by Fundación Pública Andaluza Progreso y Salud: Osteoarthritis; Tranexamic acid
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Tranexamic Acid

Study Results

No Results Posted as of Jan 18, 2020