TXA Study in Major Oncologic Surgery

NCT01980355 | Completed Results DMC

• 1 other identifier: 2012-133
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your surgical hospital stay. In this study, you will receive either the drug tranexamic acid or a placebo. The placebo looks like the tranexamic acid, but does not have any active ingredient in it. The treatment you get will be chosen by chance, like flipping a coin. You will have equal chance of being given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the placebo are considered research.

Conditions

Tranexamic Acid; Cancer; Major Surgery

Keywords

cancer; surgery; oncology; major; surgical oncology; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Required Transfusion

  To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery

  From time of surgery to 90 days post hospital discharge

Secondary Outcomes (1)

• Estimated Blood Loss

  From time of surgery to 90 days post hospital discharge

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Placebo given over 15 minutes into the vein once prior to surgery.

Other: Placebo

Interventions

Tranexamic Acid DRUG

Tranexamic Acid

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing major oncologic surgery for standard of care purposes (to include, but not limited to: liver resections, radical cholecystectomy, pancreaticoduodenectomy (Whipple procedure), esophagectomy, gastrectomy, colectomy, debulking with hyperthermic intraperitoneal chemotherapy, prostatectomies, nephrectomies and partial nephrectomies)
• Male or female \> 18 years of age
• Subject agrees to participate in this study and provides informed consent

You may not qualify if:

• Subjects with a history of hypercoagulopathy, deep vein thrombosis or pulmonary embolism
• Subjects that are on therapeutic anticoagulation or therapeutic antiplatelet medications at the time of surgery other than Aspirin
• Subjects with a history of TIA or stroke
• Subjects with a history of atrial fibrillation
• Subjects with a known thrombus
• Baseline creatinine level greater than 2.83 mg/dL
• Subjects with known hypersensitivity to tranexamic acid
• Adults unable to provide informed consent
• Children
• Pregnant women
• Prisoners
• Non-English speaking subjects
• Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health Hospitals

Grand Rapids, Michigan, 49506, United States

Location

Related Publications (9)

• Vermylen J, Verhaegen-Declercq ML, Verstraete M, Fierens F. A double blind study of the effect of tranexamic acid in essential menorrhagia. Thromb Diath Haemorrh. 1968 Dec 31;20(3):583-7. No abstract available.

  PMID: 5710474 BACKGROUND

• Casati V, Gerli C, Franco A, Torri G, D'Angelo A, Benussi S, Alfieri O. Tranexamic acid in off-pump coronary surgery: a preliminary, randomized, double-blind, placebo-controlled study. Ann Thorac Surg. 2001 Aug;72(2):470-5. doi: 10.1016/s0003-4975(01)02802-8.

  PMID: 11515884 BACKGROUND

• Massicotte L, Denault AY, Beaulieu D, Thibeault L, Hevesi Z, Roy A. Aprotinin versus tranexamic acid during liver transplantation: impact on blood product requirements and survival. Transplantation. 2011 Jun 15;91(11):1273-8. doi: 10.1097/TP.0b013e31821ab9f8.

  PMID: 21617589 BACKGROUND

• Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.

  PMID: 22012809 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

• Cap AP, Baer DG, Orman JA, Aden J, Ryan K, Blackbourne LH. Tranexamic acid for trauma patients: a critical review of the literature. J Trauma. 2011 Jul;71(1 Suppl):S9-14. doi: 10.1097/TA.0b013e31822114af.

  PMID: 21795884 BACKGROUND

• Wu CC, Ho WM, Cheng SB, Yeh DC, Wen MC, Liu TJ, P'eng FK. Perioperative parenteral tranexamic acid in liver tumor resection: a prospective randomized trial toward a "blood transfusion"-free hepatectomy. Ann Surg. 2006 Feb;243(2):173-80. doi: 10.1097/01.sla.0000197561.70972.73.

  PMID: 16432349 BACKGROUND

• Kalavrouziotis D, Voisine P, Mohammadi S, Dionne S, Dagenais F. High-dose tranexamic acid is an independent predictor of early seizure after cardiopulmonary bypass. Ann Thorac Surg. 2012 Jan;93(1):148-54. doi: 10.1016/j.athoracsur.2011.07.085. Epub 2011 Nov 4.

  PMID: 22054656 BACKGROUND

• Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2.

  PMID: 17943760 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: G. Paul Wright, MD
• Organization: Spectrum Health

paul.wright@spectrumhealth.org

6162678540

Study Officials

• Gerald P Wright, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncology and Hepatopancreaticobiliary Surgeon

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: June 12, 2012
• Primary Completion: December 1, 2017
• Study Completion: July 29, 2020
• Last Updated: August 7, 2023
• Results First Posted: May 5, 2022

Record last verified: 2023-08

Locations

US (1)