Testing of the Drug Tranexamic Acids as Prophylaxis of Bleeding in Benign Surgical Removal of the Uterus

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hillerod Hospital, Denmark
• Collaborators: Central Denmark Region; Odense University Hospital; Research grant from Nordsjællands Hospital; Rigshospitalet, Denmark; The Danish hysterectomy and hysteroscopy database; The fund of Olga Bryde
• Treatments: Tranexamic Acid

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.