TXA Study in Major Oncologic Surgery

Cancer Clinical Trial

— TXA  

Official title:

The Effect of Tranexamic Acid on Blood Loss and Transfusion Rates in Major Oncologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980355
• Other study ID #: 2012-133
• Status: Completed
• Phase: N/A
• Start date: June 12, 2012
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 29, 2020
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Major Surgery
• Tranexamic Acid

Intervention

Drug:
• Tranexamic Acid

Other:
• Placebo

Locations

Country	Name	City	State
United States	Spectrum Health Hospitals	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Estimated Blood Loss	Surgical blood loss estimation	From time of surgery to 90 days post hospital discharge