Heart Defect, Congenital Clinical Trial
Official title:
A Randomized Trial Investigating the Effect of Tranexamic Acid on Platelet Aggregation Following Infant Cardiopulmonary Bypass
| Verified date | November 2016 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Tranexamic acid is a relatively safe medicine that is used to help the body develop clots
and slow down bleeding after large surgeries. While it has already been shown to work well
in adults and older children, there is no information on whether it works, and how it works
in children younger than 6 months old. The goal of our study is to try and understand
whether and how tranexamic acid works in children younger than 6 months old who are having
open heart surgery.
We plan to study tranexamic acid by testing its effect when compared with a placebo. The
investigators will use a method called randomization - which means patients who agree to be
in the study will be entered into a computer. The computer will randomly assign them to
either receive the medicine or the placebo. We will then compare effects on the 2 groups of
patients. Our goal is to have 50 patients in each group, or 100 patients total. We will not
know whether patients receive tranexamic acid or placebo until we review the data collected
at the end of the study.
Tranexamic acid is usually given to patients in the operating room during open heart
surgery. During open heart surgery patients require cardio-pulmonary bypass which is a
machine that replaces the function of the heart and lungs for a short period of time. This
allows surgeons to do surgery on the heart itself without having to worry about it moving
during the operation. The bypass machine has lots of tubes to carry the blood around it.
When blood comes into contact with the tubing it has a tendency to clot. To prevent this
patients are given a blood thinner called heparin. Although heparin prevents clotting in the
bypass machine, it can also increase the risk of bleeding when the surgery is over. To
reduce this risk patients are given another medicine at the completion of surgery called
protamine to try and reverse the effect of the blood thinner, heparin.
Even so bleeding remains a significant problem, especially for babies after open heart
surgery. Being on the bypass machine and having a lot of suture (stitches) lines increase
that risk. In addition, the bypass machine affects the function of platelets, the main
component of the body's clotting system. We often have to replenish blood products after
surgery to try and stop the bleeding. Some centers, including we , have used the medicine
tranexamic acid to try and help with bleeding after surgery. There have been other studies
that show it helps with fibrinolysis, which is another important part of the body's clotting
system. However, that part of the clotting system is not well developed in infants and
therefore likely does not play an important role in preventing bleeding in that age group.
As such, it may be that tranexamic acid impacts platelet function as well, and it is that
effect that helps decrease post-operative bleeding in infants younger than 6 months. This
has not been previously studied. In order to study the effect that tranexamic acid has on
platelets the investigators are proposing the investigators' research trial. The
investigators plan to randomize patients to either receive tranexamic acid or placebo in the
operating room as described above. The investigators will then draw a small amount of blood
from each patient (total of approximately 1 tablespoon) and send it to a special lab for
testing of platelet function. The lab test will help us understand whether the platelets
function better when patients receive tranexamic acid instead of placebo.
The investigators will also be monitoring other outcomes related to platelet function. These
will include how much bleeding patients have after surgery when they are in the intensive
care unit, and how much blood products they require to treat that bleeding. The
investigators will also monitor labs that are checked routinely in all patients after open
heart surgery. The investigators will also track how long it takes each patient to get off
the ventilator and how long they spend in the ICU after surgery. All of this data will help
us understand whether tranexamic acid makes a positive impact on outcomes after open heart
surgery in infants less than 6 months old.
The current standard of care is quite variable within our institution as well as at other
institutions. Some anesthesiologists use tranexamic acid while others elect not to. There is
no definitive guideline to its current use. The dosing differs from center to center, and
there are some centers that do not use it at all.
The investigators' hope is that the results of this study will help us understand the role
tranexamic acid plays in preserving the function of platelets after open heart surgery in
young infants, and whether that impact translates into improved outcomes for those patients.
Based on the results of our research we hope to develop definitive guidelines for the use of
tranexamic acid in the population of infants <6 months old undergoing open heart surgery.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 6 Months |
| Eligibility |
Inclusion Criteria: 1. Infants = 6 months of age undergoing congenital cardiac surgery with cardiopulmonary bypass 2. Cyanotic and non-cyanotic congenital heart disease are eligible for enrollment 3. No patient will be excluded because of race or ethnicity 4. Parental or legal guardian consent will be obtained for all patients prior to enrollment Exclusion Criteria: 1. Documented or suspected bleeding or coagulation disorder 2. Documented history of occlusive deep venous or arterial thrombosis 3. Cardiac surgery without cardiopulmonary bypass (i.e. Blalock-Taussig shunt, coarctation of the aorta) 4. The need for mechanical circulatory support within 12 hours following cardiopulmonary bypass including extracorporeal membrane oxygenation. 5. Placement of a ventricular assist device 6. Prior enrollment in this study (Stage II Norwood who had been enrolled at their Stage I operation) 7. Parent or legal guardian unable or unwilling to consent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Platelet Aggregation | Measure the effect of tranexamic acid on whole blood platelet aggregation as measured by collagen induced platelet aggregometry. | 1 year | No |
| Secondary | Postoperative bleeding | 1 year | No |
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