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

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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

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE December 18, 2017
Results First Submitted Date  ICMJE May 28, 2019
Results First Posted Date  ICMJE September 9, 2019
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE December 21, 2017
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
Postoperative chest tube production 24 hours after surgical procedure [ Time Frame: 24 hours after surgical procedure ]
Will be analyzed with a t-test as it is a continuous variable
Change History Complete list of historical versions of study NCT03376061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • Number of Participants With Seizures [ Time Frame: Patients will be followed post-operatively until hospital discharge ]
    Patients experiencing a post-operative seizure
  • Number of Participants With Mortality [ Time Frame: Patients will be followed post-operatively until hospital discharge ]
    The occurrence of death due to any cause
  • Number of Participants With RBC Transfusion [ Time Frame: Intra-operative and post-operative RBC transfusions ]
    Patients requiring a red blood cell transfusion
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • Postoperative seizure development [ Time Frame: Seizures will be documented from date of surgery to hospital discharge date or date of death for any cause up to hospital discharge date. Whichever came first, up to one month. ]
    compared via a Fisher's exact test as the frequency will be low
  • All-cause death [ Time Frame: All-cause death will be documented from date of surgery through study completion which is 30 days post surgery date. ]
    compared via a Fisher's exact test as the frequency will be low
  • Total blood transfusions [ Time Frame: during surgery ]
    analyzed by chi-square
  • Surgical Re-exploration (bleeding/tamponade) [ Time Frame: Surgical Re-exploration (bleeding/tamponade) will be documented from date of surgery to hospital discharge date or date of death for any cause prior to hospital discharge date. Whichever came first, up to one month. ]
    compared via a Fisher's exact test as the frequency will be low
  • Length of ICU stay [ Time Frame: Number of hours in ICU are being collected at the Post-Operative Visit. Hour collection will start upon arrival at ICU post surgery and stop at ICU exit, up to one month. ]
    analyzed with a t-test
  • Level of TA [ Time Frame: on arrival in ICU within 3 hours ]
    analyzed with a t-test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Official Title  ICMJE DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Bleeding
  • Surgical Blood Loss
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tranexamic Acid
  • Active Comparator: TA Intravenous
    2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.
    Intervention: Drug: Tranexamic Acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2019)
97
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2017)
100
Actual Study Completion Date  ICMJE September 4, 2018
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 )
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03376061
Other Study ID Numbers  ICMJE DEPOSITION 1.0 2017-07-28
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andre Lamy, MD MHSc Population Health Research Institute
PRS Account Population Health Research Institute
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP