Topical Tranexamic Acid in Complex Cardiac Surgery: Does it Reduce Transfusion Need?

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-007653
    Sponsor Protocol Number: 15-007653

About this study

The goal of ths study is to determine the effectiveness of adding topical tranexamic acid (TXA) to our standard practice of care for patients undergoing redo or complex cardiac procedures. The study will use a control group for comparision.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria: 

  • Patients undergoing complex cardiac surgery (redo operations, combined operations such as CABG + valve, multiple valve)
  • Male or female
  • Patients > 18 years of age

Exclusion Criteria:

  • Patients < 18 years of age
  • Adult congenital cardiac patients
  • Patients with allergy to TXA
  • Patients with prior history of thrombosis
  • Patients who cannot grant informed consent
  • Patients with coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at the time of cardiovascular surgery
  • Patients who have received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within the past 5 days
  • Patients who are taking chronic warfarin therapy who have not discontinued treatment and demonstrated an INR <1.3 prior to surgery
  • Patients who are on IV or IM Heparin products till day of surgery.
  • Patients who are undergoing emergency open heart-surgery
  • Patients for whom procedures for which the cardiopulmonary bypass time is expected to be < 30 minutes
  • Patients for whom procedures for which the cardiopulmonary bypass is excepted to not be normothermic (temperature ≥ 35 degrees C)
  • Patients who cannot receive heparin
  • Pregnant patients
  • Patients whose preoperative creatinine is > 1.5

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sameh Said, M.D.

Open for enrollment

Contact information:

Sameh Said M.D.

(507)255-7066

Said.Sameh@mayo.edu