Clinical Trial Results:
Tranexamic acid in major vascular surgery (Tranex-AAA)
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Summary
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EudraCT number |
2014-001456-39 |
Trial protocol |
IT |
Global end of trial date |
01 Feb 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Feb 2022
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First version publication date |
17 Feb 2022
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Other versions |
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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 |
Tranex-AAA
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02335359 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
IRCCS Ospedale San Raffaele
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Sponsor organisation address |
Via Olgettina, 60, Milano, Italy, 20132
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Public contact |
Dip di Anestesia e Rianimazione, IRCCS Ospedale San Raffaele , 0039 0226436151, landoni.giovanni@hsr.it
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Scientific contact |
Dip di Anestesia e Rianimazione, IRCCS Ospedale San Raffaele , 0039 0226436151, landoni.giovanni@hsr.it
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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 |
01 Feb 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Feb 2019
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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 of this study was to determine if tranexamic acid reduces blood loss in open abdominal aortic aneurysm (AAA) surgery.
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Protection of trial subjects |
Approval by the local Ethics Committee was obtained before the beginning of the study and written informed consent was obtained from all patients at time of enrolment. Patients care was carried out by a multidisciplinary team, including 14 vascular surgeons (five first operators) and 10 anaesthesiologists. All patients underwent a full preoperative work-up. Non-aspirin antiplatelet agents were discontinued before surgery whereas aspirin was continued throughout the perioperative period. Warfarin was stopped 5 days before surgery, whereas novel oral anticoagulants were suspended 48 h before surgery. To prevent deep venous thrombosis and pulmonary thromboembolism, all patients received 4000 units of low molecular weight heparin once a day, from the evening before surgery until 4 weeks after surgery. Patient undergoing open AAA repair at our institution receive an enhanced recovery after surgery (ERAS) approach, which has been adopted since 2012.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Mar 2015
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
1 Years | ||
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 |
Italy: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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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) |
27
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From 65 to 84 years |
73
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85 years and over |
0
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Recruitment
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Recruitment details |
This single-centre, double-blinded, parallel-group, randomised clinical trial involved 100 patients older than 50yr undergoing open AAA surgical repair. Patients were asked to signed informed consent form on the day before surgery. Patients were enrolled between March 2015 and October 2017. One year of follow up was completed in November 2018 | |||||||||
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Pre-assignment
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Screening details |
Patients undergoing urgent surgery, noncollaborating or psychiatric, with known history of allergy to tranexamic acid, seizures, acute venous or arterial thrombosis, fibrinolytic conditions, severe renal insufficiency , haematuria, and with ocular disturbances, including blurred vision, poor sight or altered colour perception were excluded. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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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 |
Trial participants, care providers, and data collectors were blinded to group assignment. The treatment was prepared by a nurse who was not involved in the study or in the care of the patient.The bottle with the loading dose and the syringe for continuous i.v. infusion were labelled only with the acronym of the trial and the number of randomisation of the patient; bottles containing tranexamic acid and those containing placebo were indistinguishable
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tranexamic Acid | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Tranexamic Acid
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Investigational medicinal product code |
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Other name |
Ugurol
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
A loading dose of 500 mg of tranexamic acid diluted in 100 ml saline was intravenously
infused slowly 20 min before surgery, and a continuous intravenous infusion of tranexamic acid was then administered at a rate of 250 mg h-1 (2.5 ml h-1, using nondiluted tranexamic acid contained in the vials) from surgical incision until skin closure
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Sodium Chloride 0.9%
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Investigational medicinal product code |
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Other name |
Saline solution
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patients randomised to the control group received placebo with identical volumes and rates of infusion of patients randomised to the experimental group.
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Baseline characteristics reporting groups
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Reporting group title |
Tranexamic Acid
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tranexamic Acid
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
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End point title |
Intraoperative blood loss | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At the end of the surgery
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Statistical analysis title |
Groups comparation | ||||||||||||
Comparison groups |
Tranexamic Acid v Placebo
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Patients receiving RBC | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During surgery and until hospital discharge
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Statistical analysis title |
Groups comparation | |||||||||
Comparison groups |
Tranexamic Acid v Placebo
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared corrected | |||||||||
Confidence interval |
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End point title |
28-day mortality | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
28 days after surgery
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Statistical analysis title |
Groups comparation | |||||||||
Comparison groups |
Tranexamic Acid v Placebo
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared corrected | |||||||||
Confidence interval |
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End point title |
1-yr mortality | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
1 year after surgery
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Statistical analysis title |
Groups comparation | |||||||||
Comparison groups |
Tranexamic Acid v Placebo
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared corrected | |||||||||
Confidence interval |
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End point title |
Occurrence of thromboembolic events | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
28-days and one year after surgery
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Statistical analysis title |
Groups comparation | |||||||||
Comparison groups |
Tranexamic Acid v Placebo
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared corrected | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
During hospitalization and during follow-up phone calls
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
20
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse event associated to the IMPs were recorded. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Dec 2014 |
Changes to protocol (inclusion criteria - concomitant medication) and informed consent form relating to safety and integrity of subjects |
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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. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/31607387 |
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