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

NCT01940419 | Completed Phase 4 DMC

• 2 other identifiers: 2011-4252012-005407-40
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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

Conditions

Gynecologic Surgical Procedures; Hysterectomy; Tranexamic Acid

Keywords

Reduction of blood loss; Surgical complication; Hysterectomy; Antifibrinolytic Agents; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• Intraoperative bleeding

  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

  1 day (Bleeding is measured immediately after surgery)

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

1g Tranexamic acid iv just before surgery

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

sterile sodium chloride 9mg/ml iv

Drug: Placebo

Interventions

Tranexamic Acid DRUG

1g Tranexamic acid iv administered over 10 minutes just before surgery

Also known as: Cyklokapron

Tranexamic Acid

Placebo DRUG

10 ml sodium chloride iv administered over 10 minutes just before surgery

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18 who is to undergo elective benign hysterectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Central Denmark Region: collaborator
• Research grant from Nordsjællands Hospital: collaborator
• The fund of Olga Bryde: collaborator
• The Danish hysterectomy and hysteroscopy database: collaborator

Study Sites (1)

Department of gynecology and obstetrics, Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (9)

• Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Fergusson DA, Ker K. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011 Mar 16;2011(3):CD001886. doi: 10.1002/14651858.CD001886.pub4.

  PMID: 21412876 BACKGROUND

• CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

  PMID: 20554319 BACKGROUND

• Lethaby A, Farquhar C, Cooke I. Antifibrinolytics for heavy menstrual bleeding. Cochrane Database Syst Rev. 2000;(4):CD000249. doi: 10.1002/14651858.CD000249.

  PMID: 11034679 BACKGROUND

• Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.

  PMID: 10400410 BACKGROUND

• Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984.

  PMID: 21196541 BACKGROUND

• Astedt B, Liedholm P, Wingerup L. The effect of tranexamic acid on the fibrinolytic activity of vein walls. Ann Chir Gynaecol. 1978;67(6):203-5.

  PMID: 742821 BACKGROUND

• Lukes AS, Moore KA, Muse KN, Gersten JK, Hecht BR, Edlund M, Richter HE, Eder SE, Attia GR, Patrick DL, Rubin A, Shangold GA. Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):865-875. doi: 10.1097/AOG.0b013e3181f20177.

  PMID: 20859150 BACKGROUND

• Bonnar J, Sheppard BL. Treatment of menorrhagia during menstruation: randomised controlled trial of ethamsylate, mefenamic acid, and tranexamic acid. BMJ. 1996 Sep 7;313(7057):579-82. doi: 10.1136/bmj.313.7057.579.

  PMID: 8806245 BACKGROUND

• Coulter A, Kelland J, Peto V, Rees MC. Treating menorrhagia in primary care. An overview of drug trials and a survey of prescribing practice. Int J Technol Assess Health Care. 1995 Summer;11(3):456-71. doi: 10.1017/s0266462300008679.

  PMID: 7591547 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Märta F Topsøe, DM

  Department of gynecology and obstetrics, Nordsjællands Hospital, 3400 Hillerød

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DM, PhD-student

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

DK (1)