Clinical trial NCT03376061: Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Official title: DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Surgical Blood Loss
Keywords: Tranexamic Acid
Cardiac surgery
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Primary purpose: PREVENTION

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.

Eligibility 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 )

Primary outcomes:
measure: Median Volume of Mediastinal Fluid Collected From Participants
timeFrame: Fluid collected in the first 24 hours after the surgical procedure
Secondary outcomes:
measure: Number of Participants With Seizures
timeFrame: Patients will be followed post-operatively until hospital discharge
measure: Number of Participants With Mortality
timeFrame: Patients will be followed post-operatively until hospital discharge
measure: Number of Participants With RBC Transfusion
timeFrame: Intra-operative and post-operative RBC transfusions
measure: Number of Participants With Re-operation for Bleeding or Tamponade
timeFrame: Patients will be followed post-operatively until hospital discharge
measure: Median Number of Hours Participants Spent in ICU
timeFrame: Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).
measure: Mean Concentration of TxA in Plasma Collected From Participants
timeFrame: on arrival in ICU within 3 hours
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Andre Lamy, MD MHSc
role: PRINCIPAL_INVESTIGATOR
References:
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