Hysterectomy Clinical Trial
Official title:
Peroperative Tranexamic Acid as Prophylaxis of Haemorrhage in Benign Hysterectomy - a Randomized, Placebo-controlled Trial
In Denmark, 4400 women annually undergo hysterectomy on benign background (surgical removal of the uterus). 10% of these women experience bleeding complications. The drug Tranexamic Acid (Cyklokapron) has showed significant reduction of bleeding in relation to other types of surgery. The hypothesis of this study is that Tranexamic Acid could also reduce the operative bleeding associated with benign hysterectomy. The study will be carried out as a randomized, placebo-controlled national multicenter trial
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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