Clinical Trial Results:
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.
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Summary
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EudraCT number |
2017-002480-17 |
Trial protocol |
ES |
Global end of trial date |
18 Feb 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Mar 2021
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First version publication date |
21 Mar 2021
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Other versions |
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Summary report(s) |
results report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FPS-TRA-2017-02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03386656 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundación Pública Andaluza Progreso y Salud
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Sponsor organisation address |
Parque Científico y Tecnológico Cartuja Avda. Américo Vespucio, 15. Edificio S-2. 41092 Sevilla, Seville, Spain, 41092
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Public contact |
Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, 0034 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
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Scientific contact |
Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, 0034 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Feb 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Feb 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Feb 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The aim objective is to compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed of severe knee osteoarthritis in total primary knee prosthesis, in blood loss decrease (estimated blood loss, low hemoglobin, low hematocrit), and to assess the safety profile of topical tranexamic acid in patients subjected to prosthetic knee surgery.
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Protection of trial subjects |
The trial will be conducted in accordance with the recommendations for Clinical Trials and Investigational Product Evaluation in humans, as contained in the Declaration of Helsinki, as revised at successive World Assemblies (WMA, 2013) (see Annex IV), and the current Spanish Clinical Trial Legislation (RD 1090/2015). The ICH-GCP standards (CPMP/ICH/135/95) will be followed.
The sponsor will obtain authorisation from the Health Authorities (AEMPS), in accordance with all applicable country-specific legal requirements. The study will not commence until AEMPS authorisation and Ethics Committee approval has been obtained.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Sep 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 150
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Worldwide total number of subjects |
150
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EEA total number of subjects |
150
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
31
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From 65 to 84 years |
119
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85 years and over |
0
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Recruitment
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Recruitment details |
The sample of this study is made up of patients of both sexes aged between 18 and 80 diagnosed with severe osteoarthritis of the knee who have an indication for Primary Prosthetic Knee Surgery, under follow-up by the Lower Limb Unit of the Puerta del Mar Hospital at the date of the start of the study. | |||||||||
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Pre-assignment
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Screening details |
Selection criteria, written, signed and dated informed consent, socio-demographic data, anthropometric data, concomitant pharmacological treatment, record of comorbidities and pregnancy test shall be performed. | |||||||||
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Period 1
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Period 1 title |
recruitment and patient follow-up
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
The medication in both treatment groups will have the same packaging and labelling, as well as the same volume, weight and organoleptic characteristics. Each package will be identified with an individual randomisation code corresponding to a patient. The clinical management of the patient should be identical, regardless of the assigned treatment.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
tranexamic acid (Amchafibrin)
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Investigational medicinal product code |
B02AA02
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Topical use
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Dosage and administration details |
3 g topical solution
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Physiological Saline Solution 0.9%
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Investigational medicinal product code |
B05BB
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Topical use
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Dosage and administration details |
3 g in a 30 cc aqueous solution
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Period 2
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Period 2 title |
Data analysis
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Is this the baseline period? |
No | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
tranexamic acid (Amchafibrin)
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Investigational medicinal product code |
B02AA02
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Topical use
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Dosage and administration details |
3 g topical solution
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Physiological Saline Solution 0.9%
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Investigational medicinal product code |
B05BB
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Topical use
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Dosage and administration details |
3 g in a 30 cc aqueous solution
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
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Reporting group title |
Control
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Reporting group description |
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
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Reporting group title |
Control
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Reporting group description |
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Reporting group title |
Intervention
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Reporting group description |
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Reporting group title |
Control
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Reporting group description |
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End point title |
Previous Haemoglobin [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As we do not have information on all the sections required in this point, we have decided not to complete it, however, we will upload a pdf with the results report that includes reference to this point. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Posterior haemoglobin [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As we do not have information on all the sections required in this point, we have decided not to complete it, however, we will upload a pdf with the results report that includes reference to this point. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Total blood loss (TBL) [3] | ||||||||||||
End point description |
It can be stated that there are significant differences in total blood loss (TBL) comparing the group treated with tranexamic acid versus placebo. The patients who did not receive tranexamic acid had a greater blood loss than those who did not.
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As we do not have information on all the sections required in this point, we have decided not to complete it, however, we will upload a pdf with the results report that includes reference to this point. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Evolution | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the follow-up
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Beginning of Bipedestation | |||||||||||||||||||||
End point description |
The distribution of the time of onset of standing according to treatment is homogeneous in percentage terms. The fisher's exact test was performed to compare all categories due to the low number of observations in the latter categories. No statistically significant differences were found (p-value=0.55).
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End point type |
Secondary
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End point timeframe |
During the follow-up
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
EVA scale one month after the intervention | |||||||||||||||||||||
End point description |
The distribution of scores on the EVA scale according to treatment is homogeneous in percentage terms. The x2 test was performed to compare all defined ranges of the scale. No statistically significant differences were found (p-value=0.82).
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End point type |
Secondary
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End point timeframe |
One month after the intervention
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| No statistical analyses for this end point | ||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From first visit of first patient to last visit of last patient.
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Adverse event reporting additional description |
Most of the adverse events (AEs) recorded were not related to the trial medication, but to knee oedema (in 1 subject, in addition to oedema, mild haematoma was detected) (no treatment required); or pain treated by home treatment in hospital. In addition, diarrhoea was detected in 1 subject who did not require treatment.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 4% | ||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| - Subjects are not necessarily representative of the entire population in Cadiz. - Refusal to participate. - Losses in the follow-up. | |||
