Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

Bleeding Clinical Trial

— DEPOSITION  

Official title:

DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376061
• Other study ID #: DEPOSITION 1.0 2017-07-28
• Status: Completed
• Phase: Phase 4
• Start date: December 21, 2017
• Est. completion date: September 4, 2018

Study information

• Verified date: January 2021
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.

Description:

Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TA is used directly on the tissues (topically) for other type of surgeries (joints), TA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 4, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female >= 18 years old
• Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy
• Provide written informed consent

Exclusion Criteria:

• Poor (English) language comprehension
• Minimally invasive valve surgery
• Off-pump procedures
• Emergency operations
• Known history of increased bleeding disorder
• Thromboembolic disease
• Allergy to tranexamic acid
• Severe renal impairment (eGFR <30 mL/min/1.73m2 )

Related Conditions & MeSH terms

• Bleeding
• Blood Loss, Surgical
• Hemorrhage
• Postoperative Hemorrhage
• Surgical Blood Loss

Intervention

Drug:
• Tranexamic Acid
Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Despotis GJ, Santoro SA, Spitznagel E, Kater KM, Cox JL, Barnes P, Lappas DG. Prospective evaluation and clinical utility of on-site monitoring of coagulation in patients undergoing cardiac operation. J Thorac Cardiovasc Surg. 1994 Jan;107(1):271-9. — View Citation

Harker LA, Malpass TW, Branson HE, Hessel EA 2nd, Slichter SJ. Mechanism of abnormal bleeding in patients undergoing cardiopulmonary bypass: acquired transient platelet dysfunction associated with selective alpha-granule release. Blood. 1980 Nov;56(5):824-34. — 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

Kucuk O, Kwaan HC, Frederickson J, Wade L, Green D. Increased fibrinolytic activity in patients undergoing cardiopulmonary bypass operation. Am J Hematol. 1986 Nov;23(3):223-9. — View Citation

Lemmer JH Jr, Stanford W, Bonney SL, Breen JF, Chomka EV, Eldredge WJ, Holt WW, Karp RB, Laub GW, Lipton MJ, et al. Aprotinin for coronary bypass operations: efficacy, safety, and influence on early saphenous vein graft patency. A multicenter, randomized, double-blind, placebo-controlled study. J Thorac Cardiovasc Surg. 1994 Feb;107(2):543-51; discussion 551-3. — View Citation

Martin K, Wiesner G, Breuer T, Lange R, Tassani P. The risks of aprotinin and tranexamic acid in cardiac surgery: a one-year follow-up of 1188 consecutive patients. Anesth Analg. 2008 Dec;107(6):1783-90. doi: 10.1213/ane.0b013e318184bc20. — View Citation

Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussières JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23. Erratum in: N Engl J Med. 2018 Feb 22;378(8):782. — View Citation

Pleym H, Stenseth R, Wahba A, Bjella L, Karevold A, Dale O. Single-dose tranexamic acid reduces postoperative bleeding after coronary surgery in patients treated with aspirin until surgery. Anesth Analg. 2003 Apr;96(4):923-8, table of contents. — View Citation

Santos AT, Kalil RA, Bauemann C, Pereira JB, Nesralla IA. A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting. Braz J Med Biol Res. 2006 Jan;39(1):63-9. Epub 2005 Dec 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Volume of Mediastinal Fluid Collected From Participants	Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure	Fluid collected in the first 24 hours after the surgical procedure
Secondary	Number of Participants With Seizures	Patients experiencing a post-operative seizure	Patients will be followed post-operatively until hospital discharge
Secondary	Number of Participants With Mortality	The occurrence of death due to any cause	Patients will be followed post-operatively until hospital discharge
Secondary	Number of Participants With RBC Transfusion	Patients requiring a red blood cell transfusion	Intra-operative and post-operative RBC transfusions
Secondary	Number of Participants With Re-operation for Bleeding or Tamponade	Occurrence of re-operation for the purpose of bleeding or cardiac tamponade	Patients will be followed post-operatively until hospital discharge
Secondary	Median Number of Hours Participants Spent in ICU	Number of hours participants spent in the intensive care unit (ICU)	Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).
Secondary	Mean Concentration of TxA in Plasma Collected From Participants	Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU	on arrival in ICU within 3 hours