Back to resultsEfficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery (TRA)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Amchafibrin
Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Tranexamic acid
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario Puerta del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Amchafibrin
Saline Solution 0,9%.
Arm Description
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.
Comparator of tranexamic acid
Outcomes
Primary Outcome Measures
Saving blood loss in knee surgery
Total blood loss greater than 245 ml
Secondary Outcome Measures
Time post-intervention of functional recovery in study subjects
Length of hospital stay in study subjects
Full Information
NCT ID
NCT03386656
First Posted
June 26, 2017
Last Updated
January 14, 2020
Sponsor
Fundación Pública Andaluza Progreso y Salud
1. Study Identification
Unique Protocol Identification Number
NCT03386656
Brief Title
Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery
Acronym
TRA
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza Progreso y Salud
4. Oversight
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
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Tranexamic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amchafibrin
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline Solution 0,9%.
Arm Type
Placebo Comparator
Arm Description
Comparator of tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Amchafibrin
Intervention Description
Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
Intervention Type
Other
Intervention Name(s)
Saline Solution
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Saving blood loss in knee surgery
Description
Total blood loss greater than 245 ml
Time Frame
24 hours post-intervention
Secondary Outcome Measure Information:
Title
Time post-intervention of functional recovery in study subjects
Time Frame
Four weeks post-discharger
Title
Length of hospital stay in study subjects
Time Frame
Four weeks post-discharger
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery
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