Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376061
Recruitment Status : Completed
First Posted : December 18, 2017
Results First Posted : September 9, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Bleeding Surgical Blood Loss Drug: Tranexamic Acid Phase 4

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The pharmacy will prepare 1 syringe of 50 ml of topical TA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.
Primary Purpose: Prevention
Official Title: DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TA Topical
1 syringe of 50ml of topical Tranexamic Acid (5g) or placebo. The topical will be poured into the pericardial mediastinal cavities in 2 equal doses, 25ml when the pt comes off-pump and the other 25ml before sternotomy is closed.
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.
Other Name: Cyklokapron

Active Comparator: TA Intravenous
2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.
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.
Other Name: Cyklokapron




Primary Outcome Measures :
  1. Median Volume of Mediastinal Fluid Collected From Participants [ Time Frame: Fluid collected in the first 24 hours after the surgical procedure ]
    Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure


Secondary Outcome Measures :
  1. Number of Participants With Seizures [ Time Frame: Patients will be followed post-operatively until hospital discharge ]
    Patients experiencing a post-operative seizure

  2. Number of Participants With Mortality [ Time Frame: Patients will be followed post-operatively until hospital discharge ]
    The occurrence of death due to any cause

  3. Number of Participants With RBC Transfusion [ Time Frame: Intra-operative and post-operative RBC transfusions ]
    Patients requiring a red blood cell transfusion

  4. Number of Participants With Re-operation for Bleeding or Tamponade [ Time Frame: Patients will be followed post-operatively until hospital discharge ]
    Occurrence of re-operation for the purpose of bleeding or cardiac tamponade

  5. Median Number of Hours Participants Spent in ICU [ Time Frame: Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit). ]
    Number of hours participants spent in the intensive care unit (ICU)

  6. Mean Concentration of TxA in Plasma Collected From Participants [ Time Frame: on arrival in ICU within 3 hours ]
    Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376061


Locations
Layout table for location information
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Andre Lamy, MD MHSc Population Health Research Institute
  Study Documents (Full-Text)

Documents provided by Population Health Research Institute:

Publications:

Layout table for additonal information
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03376061     History of Changes
Other Study ID Numbers: DEPOSITION 1.0 2017-07-28
First Posted: December 18, 2017    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
Tranexamic Acid
Cardiac surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants