TXA Study in Major Oncologic Surgery

NCT ID: NCT01980355

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-12
• Study Completion Date: 2020-07-29

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.

Detailed Description

Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor will know which treatment you are getting.

You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.

Information from your medical record related to your surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with your study number instead of your name. Additionally, if you return to the hospital within 90 days after you went home from the hospital, information about that hospital visit(s) will also be collected from your medical record.

Conditions

Tranexamic Acid; Cancer; Major Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Tranexamic Acid

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Gerald P. Wright

Surgical Oncology and Hepatopancreaticobiliary Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald P Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 5710474 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11515884 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21617589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22012809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20554319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21795884 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16432349 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22054656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17943760 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2012-133

Identifier Type: -

Identifier Source: org_study_id