Testing of the Drug Tranexamic Acids as Prophylaxis of Bleeding in Benign Surgical Removal of the Uterus (PeTraH)
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|ClinicalTrials.gov Identifier: NCT01940419|
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : October 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Surgical Procedures Hysterectomy Tranexamic Acid||Drug: Tranexamic Acid Drug: Placebo||Phase 4|
In Denmark, there are approximately 4400 elective benign hysterectomies annually. In about 10% of these there will occur a per- or postoperative bleeding complications with increased hospital stay, reoperations and prolonged sick leave as a result. The pharmaceutical product 'Tranexamic acid' has proved to be effective in reducing blood loss in other forms of surgery, in trauma patients, and in relation to certain medical conditions. The hypothesis of the proposed study is that Tranexamic acid could also reduce the operative bleeding associated with hysterectomy on benign indications. Based on the literature and previous studies, the objective of the trial is an average bleeding reduction of 25%.
The clinical trial will be conducted as a randomized, placebo-controlled, double blind multicenter trial in gynecological departments several places in Denmark: Nordsjællands Hospital, Rigshospitalet, Odense University Hospital and Aarhus University Hospital - Skejby. The subjects will be recruited in outpatient clinics of the gynecological departments. During the study there will be an ongoing monitoring by external partner. The experiment is approved by all relevant bodies. The total period of time in which the trial is planned to last is one year commencing 01.02.3013 and ending 28.02.2014. All together the trial will include 314 participants determined by presumed bleeding reduction, the average bleeding on hysterectomy and type 1 error of 0.05 and type 2 error of 0.20. Randomization will be conducted electronically and both clinician, patient and data collector we will be blinded. Data for the study will partly be collected through registrations to the already well established and well functioning Danish Hysterectomy and Hysteroscopy Database. Data used in relation to the study will be validated by examining the manual records in conjunction with data extraction. The results will be analyzed by univariate and multivariate analyzes and static regression analyzes. All final results from the study will be sought published in recognized international journals.
Regarding ethical aspects it is noted that the study is carried out with the highest standard of design, and with a proven drug without unexpected side effects or disadvantages. In the literature, there seems no evidence to suspect an increased risk of blood clot formation using the drug. However, it seems clear that the incidence of complications associated with hysterectomy is quite high. It is therefore ethically fully responsible and appropriate to carry out the planned study with the desire to ensure the quality and improve hysterectomy, surgery.
The project is supported by funds and receives no commercial support.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Peroperative Tranexamic Acid as Prophylaxis of Haemorrhage in Benign Hysterectomy - a Randomized, Placebo-controlled Trial|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||October 2015|
Active Comparator: Tranexamic Acid
1g Tranexamic acid iv just before surgery
Drug: Tranexamic Acid
1g Tranexamic acid iv administered over 10 minutes just before surgery
Other Name: Cyklokapron
Placebo Comparator: Placebo
sterile sodium chloride 9mg/ml iv
10 ml sodium chloride iv administered over 10 minutes just before surgery
- Intraoperative bleeding [ Time Frame: 1 day (Bleeding is measured immediately after surgery) ]In relation to the trial there is at set of standards to objectify blood loss during surgery. Output and input will be weighed and will form the basis of the calculated operative blood loss
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940419
|Department of gynecology and obstetrics, Nordsjællands Hospital|
|Hillerød, Denmark, 3400|
|Principal Investigator:||Märta F Topsøe, DM||Department of gynecology and obstetrics, Nordsjællands Hospital, 3400 Hillerød|