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Trial record 32 of 420 for:    TRANEXAMIC ACID

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
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Odense University Hospital
Central Denmark Region
Research grant from Nordsjællands Hospital
The fund of Olga Bryde
The Danish hysterectomy and hysteroscopy database
Information provided by (Responsible Party):
Märta Fink Topsøe, Hillerod Hospital, Denmark

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Gynecologic Surgical Procedures Hysterectomy Tranexamic Acid Drug: Tranexamic Acid Drug: Placebo Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Placebo
10 ml sodium chloride iv administered over 10 minutes just before surgery




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Women over 18 who is to undergo elective benign hysterectomy

Exclusion Criteria:

  • Known thrombophilia
  • Active / previous thromboembolic disease
  • Family history of thromboembolic disease (thrombophilia in the family)
  • Hypersensitivity to any ingredient in Tranexamic acid
  • Renal impairment
  • Ongoing hematuria
  • Subarachnoid hemorrhage
  • Daily use of any type of blood thinners (Clopidogrel / Marevan / Warfarin / Nonsteroidal Antiinflammatory Drugs (not when pain is the indication))
  • Preoperative use of Tranexamic acid within 24 hours of the operation
  • Known malignancy or hysterectomy as part of the investigation for suspected malignancy
  • Insufficient understanding of the information concerning the project: language disabilities, intellectual limitations, or the like.

Information from the National Library of Medicine

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


Locations
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Denmark
Department of gynecology and obstetrics, Nordsjællands Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Rigshospitalet, Denmark
Odense University Hospital
Central Denmark Region
Research grant from Nordsjællands Hospital
The fund of Olga Bryde
The Danish hysterectomy and hysteroscopy database
Investigators
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Principal Investigator: Märta F Topsøe, DM Department of gynecology and obstetrics, Nordsjællands Hospital, 3400 Hillerød

Publications:

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Responsible Party: Märta Fink Topsøe, DM, PhD-student, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01940419     History of Changes
Other Study ID Numbers: 2011-425
2012-005407-40 ( EudraCT Number )
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Keywords provided by Märta Fink Topsøe, Hillerod Hospital, Denmark:
Reduction of blood loss
Surgical complication
Hysterectomy
Antifibrinolytic Agents
Randomized Controlled Trials
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants