Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

NCT04311073 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 19-08-FB-0189
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision.

Conditions

Fibroid Uterus; Abnormal Uterine Bleeding; Myoma;Uterus

Keywords

Tranexamic acid; Minimally Invasive; Myomectomy; Fibroid

Outcome Measures

Primary Outcomes (3)

• Estimated blood loss

  Estimated blood loss at time of procedure completion; using volume of cannister and weight of lap sponges

  Duration of procedure up to 420 minutes

• Calculated blood loss

  Calculated Blood loss, using pre-operative hematocrit, postoperative hematocrit and estimated blood volume x Body Mass Index

  From post operative day 0 until postoperative day 1

• Number of blood products received

  Number of blood products received during admission that is directly due to blood loss at time of procedure

  Duration of hospital stay up to two days

Secondary Outcomes (11)

• Duration of surgery

  Duration of surgery up to 420 minutes

• Length of hospital stay

  Duration of stay in hospital, up to two days

• Number of fibroids removed

  Duration of surgery, up to 420 minutes

• Fibroid type

  through completion of study average 8 weeks

• Weight of fibroids removed

  duration of surgery up to 420 minutes

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Patients will receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline 15 minutes prior to initial surgical incision time

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Patients will receive an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision

Drug: Placebos

Interventions

Tranexamic Acid DRUG

IV Tranexamic acid in 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

Tranexamic Acid

Placebos DRUG

IV normal saline 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing laparoscopic myomectomy
• At least one fibroid greater than or equal to 6 cm
• Any intramural or broad ligament fibroid greater than or equal to 4 cm
• At least 3 total fibroids based on preoperative imaging

You may not qualify if:

• Severe existing medical complications involving the heart, liver, or kidney
• Moderate to severe renal impairment (serum creatinine \> 1.4)
• Blood clotting abnormalities
• Known Allergies to tranexamic acid
• Known Contraindications to Minimally invasive myomectomies
• If you are pregnant
• History of a prior blood clot in the lung arm or leg, known as pulmonary embolism or deep vein thrombosis
• Any active blood clots, clotting disease, pulmonary embolism, cerebral thrombosis, estrogen use, renal impairment, elevated creatinine level
• History of a stroke or mini-strokes
• Concurrent oral contraceptive use
• Contraindications to receiving Tranexamic acid
• In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity
• In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients.
• In patients with active intravascular clotting.
• In patients with hypersensitivity to tranexamic acid or any of the ingredients

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

EasternVMC

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (10)

• Topsoee MF, Settnes A, Ottesen B, Bergholt T. A systematic review and meta-analysis of the effect of prophylactic tranexamic acid treatment in major benign uterine surgery. Int J Gynaecol Obstet. 2017 Feb;136(2):120-127. doi: 10.1002/ijgo.12047. Epub 2016 Dec 9.

  PMID: 28099726 BACKGROUND

• Moore EE, Moore HB, Gonzalez E, Chapman MP, Hansen KC, Sauaia A, Silliman CC, Banerjee A. Postinjury fibrinolysis shutdown: Rationale for selective tranexamic acid. J Trauma Acute Care Surg. 2015 Jun;78(6 Suppl 1):S65-9. doi: 10.1097/TA.0000000000000634.

  PMID: 26002266 BACKGROUND

• Hickman LC, Kotlyar A, Shue S, Falcone T. Hemostatic Techniques for Myomectomy: An Evidence-Based Approach. J Minim Invasive Gynecol. 2016 May-Jun;23(4):497-504. doi: 10.1016/j.jmig.2016.01.026. Epub 2016 Mar 9.

  PMID: 26855249 BACKGROUND

• 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 Jan 19;(1):CD001886. doi: 10.1002/14651858.CD001886.pub3.

  PMID: 21249650 BACKGROUND

• Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.

  PMID: 25125317 BACKGROUND

• Opoku-Anane J, Vargas MV, Moawad G, Cherie M, Robinson JK. Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-Blind Placebo Controlled Trial. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S197. doi: 10.1016/j.jmig.2015.08.715. Epub 2015 Oct 15. No abstract available.

  PMID: 27679021 BACKGROUND

• Parker WH. Uterine myomas: management. Fertil Steril. 2007 Aug;88(2):255-71. doi: 10.1016/j.fertnstert.2007.06.044. Epub 2007 Jul 20.

  PMID: 17658523 BACKGROUND

• Lam SJ, Best S, Kumar S. The impact of fibroid characteristics on pregnancy outcome. Am J Obstet Gynecol. 2014 Oct;211(4):395.e1-5. doi: 10.1016/j.ajog.2014.03.066. Epub 2014 Apr 3.

  PMID: 24705132 BACKGROUND

• WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK493081/

  PMID: 29630190 BACKGROUND

• Ngichabe S, Obura T, Stones W. Intravenous tranexamic acid as an adjunct haemostat to ornipressin during open myomectomy. A randomized double blind placebo controlled trial. Ann Surg Innov Res. 2015 Oct 31;9:10. doi: 10.1186/s13022-015-0017-y. eCollection 2015.

  PMID: 26568770 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Metrorrhagia; Myofibroma

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Seifeldin Sadek, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seifeldin Sadek, MD

CONTACT

7574467100; sadeks@evms.edu

Traci Ito, MD

CONTACT

7574467900; itoTE@evms.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Double Blind Placebo clinical trial

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: March 17, 2020
• Study Start: June 20, 2020
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)