Clinical Trial Results:
Peroperative Tranexamic acid as prophylaxis of bleeding related to benign hysterectomy - a randomized, placebo-controlled trial
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Summary
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EudraCT number |
2012-005407-40 |
Trial protocol |
DK |
Global end of trial date |
30 Dec 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Feb 2022
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First version publication date |
18 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 |
2011-425
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01940419 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Hillerød Hospital
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Sponsor organisation address |
Dyrehavevej 18, HIllerød, Denmark, 3400
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Public contact |
Märta Fink Topsøe, Hillerød Hospital, department of gynecology and obstetrics, 0045 28 41 48 17, Maerta.Topsoee-Jensen@regionh.dk
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Scientific contact |
Märta Fink Topsøe, Hillerød Hospital, department of gynecology and obstetrics, 0045 28 41 48 17, Maerta.Topsoee-Jensen@regionh.dk
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Sponsor organisation name |
Nordsjællands Hospital
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Sponsor organisation address |
Dyrehavevej 18, Hillerød, Denmark, 3400
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Public contact |
Professor Ellen Løkkegaard, Hillerød Hospital, 0045 48294829, Ellen.Christine.Leth.Loekkegaard@regionh.dk
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Scientific contact |
Professor Ellen Løkkegaard, Hillerød Hospital, 0045 48294829, Ellen.Christine.Leth.Loekkegaard@regionh.dk
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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 Sep 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Dec 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Dec 2014
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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 purpose of the study is primarily to investigate Tranexamic acid's impact on preventing perioperative bleeding in benign hysterectomy. This will be investigated both by individual assessment of the intraoperative bleeding in ml, and by using relevant quantitative and qualitative secondary endpoints. The results are also expected to indicate a possible effect of Tranexamic acid on the number of actual intra- and postoperative bleeding complications, and may in this respect be considered as a pilot study.
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Protection of trial subjects |
None as the intervention under study was not considered harmful during trial.
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Background therapy |
Standard operative techniques, anaesthesi and pain-treatment in relation to conventional Hysterectomy. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Mar 2013
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
1 Months | ||
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 |
Denmark: 342
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Worldwide total number of subjects |
342
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EEA total number of subjects |
342
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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) |
298
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From 65 to 84 years |
43
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85 years and over |
1
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Recruitment
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Recruitment details |
Potential participants were identified and screened at the 4 participating Departments if they were scheduled for hysterectomy for any benign indication. | |||||||||
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Pre-assignment
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Screening details |
All potentially eligible women were informed about the study by a physician or a research nurse. They were excluded if they had thrombophilia, active thrombotic disease, any allergy to Tranexamic Acid, renal impairment, hematuria, malignant disease or received any anti-thrombotic medication. | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
342 | |||||||||
Number of subjects completed |
332 | |||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 5 | |||||||||
Reason: Number of subjects |
Physician decision: 1 | |||||||||
Reason: Number of subjects |
Surgery postponed: 4 | |||||||||
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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 [1] | |||||||||
Roles blinded |
Subject, Assessor | |||||||||
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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 |
Intervention | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Tranexamic Acid
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
Tranexamic Acid 1 gram intravenously
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Arm title
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Placebo | |||||||||
Arm description |
Placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
sodium chloride
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
100 ml intravenously
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| Notes [1] - The roles blinded appear to be inconsistent with a double blind trial. Justification: The intervention was blinded to the participants as well as the assessors. |
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| Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: We included 342 patients in the trial, 10 were not randomized, and consequently the remaining 332 women concluded the study. |
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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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 |
Intervention | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||
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End point title |
Total Blood loss estimates by surgeon | |||||||||||||||
End point description |
Blood loss estimated by the surgeon
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End point type |
Primary
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End point timeframe |
During surgery
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Statistical analysis title |
T test | |||||||||||||||
Statistical analysis description |
T test analysis
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Comparison groups |
Intervention v Placebo
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Number of subjects included in analysis |
330
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.05 | |||||||||||||||
Method |
t-test, 2-sided | |||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
4 weeks
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Adverse event reporting additional description |
The participant were assessed at discharge after surgery and again by questionnaire 4 weeks after surgery.
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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 |
12.0
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Reporting groups
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Reporting group title |
TA exposed
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Saline Exposed
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Reporting group description |
Women having placebo (saline infusion) | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 2% | ||||||||||||||||
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| 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: There was indeed no non-serious events in relation to this trial. |
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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. | |||
| None reported | |||
