TXA Study in Major Oncologic Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/25/2018 |
| Start Date: | June 2012 |
| End Date: | November 2018 |
The Effect of Tranexamic Acid on Blood Loss and Transfusion Rates in Major Oncologic Surgery
Major surgery can result in blood loss that can require a blood transfusion during and/or
after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a
treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied
in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We
believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in
reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs
related to your surgical hospital stay.
In this study, you will receive either the drug tranexamic acid or a placebo. The placebo
looks like the tranexamic acid, but does not have any active ingredient in it. The treatment
you get will be chosen by chance, like flipping a coin. You will have equal chance of being
given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the
placebo are considered research.
after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a
treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied
in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We
believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in
reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs
related to your surgical hospital stay.
In this study, you will receive either the drug tranexamic acid or a placebo. The placebo
looks like the tranexamic acid, but does not have any active ingredient in it. The treatment
you get will be chosen by chance, like flipping a coin. You will have equal chance of being
given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the
placebo are considered research.
Neither you nor the study doctor will choose what treatment you get. You will have an equal
chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor
will know which treatment you are getting.
You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before
surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.
Information from your medical record related to your surgery and recovery time in the
hospital will be collected by medical staff assisting with this study and recorded on study
forms. These study forms will be labeled with your study number instead of your name.
Additionally, if you return to the hospital within 90 days after you went home from the
hospital, information about that hospital visit(s) will also be collected from your medical
record.
chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor
will know which treatment you are getting.
You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before
surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.
Information from your medical record related to your surgery and recovery time in the
hospital will be collected by medical staff assisting with this study and recorded on study
forms. These study forms will be labeled with your study number instead of your name.
Additionally, if you return to the hospital within 90 days after you went home from the
hospital, information about that hospital visit(s) will also be collected from your medical
record.
Inclusion Criteria
- Subjects undergoing major oncologic surgery for standard of care purposes (to include,
but not limited to: liver resections, radical cholecystectomy, pancreaticoduodenectomy
(Whipple procedure), esophagectomy, gastrectomy, colectomy, debulking with
hyperthermic intraperitoneal chemotherapy, prostatectomies, nephrectomies and partial
nephrectomies)
- Male or female > 18 years of age
- Subject agrees to participate in this study and provides informed consent
Exclusion Criteria
- Subjects with a history of hypercoagulopathy, deep vein thrombosis or pulmonary
embolism
- Subjects that are on therapeutic anticoagulation or therapeutic antiplatelet
medications at the time of surgery other than Aspirin
- Subjects with a history of TIA or stroke
- Subjects with a history of atrial fibrillation
- Subjects with a known thrombus
- Baseline creatinine level greater than 2.83 mg/dL
- Subjects with known hypersensitivity to tranexamic acid
- Adults unable to provide informed consent
- Children
- Pregnant women
- Prisoners
- Non-English speaking subjects
- Any other medical condition including mental illness or substance abuse deemed by the
investigator to be likely to interfere with a subject's ability to provide informed
consent, cooperate and take part in this research study
We found this trial at
1
site
Grand Rapids, Michigan 49503
Principal Investigator: Matthew H Chung, MD
Phone: 616-486-2074
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