Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 8/15/2018 |
Start Date: | May 19, 2017 |
End Date: | May 2021 |
Contact: | Bryan S. Moon, MD |
Email: | bsmoon@mdanderson.org |
Phone: | 713-745-4117 |
The goal of this clinical research study is to determine if tranexamic acid can help in
reduction of blood and blood product loss before, during, and after surgery.
reduction of blood and blood product loss before, during, and after surgery.
Study Groups:
If participant agrees to take part in this study, participant will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study
group is better, the same, or worse than the other group. Participant will have an equal
chance of being assigned to either group.
During surgery, one group will receive the study drug by vein and the other group will not.
The study staff and surgeons will know if participant is receiving the study drug or not.
Surgery:
Participant will have participant's surgery as planned. Participant will sign a separate
consent for the surgery that explains the procedure and the risks.
Medical Information Collection:
Researchers will collect information from participant's medical record before, during, and
after the surgery for this study.
Blood Draws:
Blood (about 2-4 teaspoons each time) will be drawn for routine tests 1 time daily for the 7
days directly after surgery.
Length of Study Participation:
Participation on the study will be over after participant's routine blood draw 7 days after
surgery.
This is an investigational study.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
If participant agrees to take part in this study, participant will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study
group is better, the same, or worse than the other group. Participant will have an equal
chance of being assigned to either group.
During surgery, one group will receive the study drug by vein and the other group will not.
The study staff and surgeons will know if participant is receiving the study drug or not.
Surgery:
Participant will have participant's surgery as planned. Participant will sign a separate
consent for the surgery that explains the procedure and the risks.
Medical Information Collection:
Researchers will collect information from participant's medical record before, during, and
after the surgery for this study.
Blood Draws:
Blood (about 2-4 teaspoons each time) will be drawn for routine tests 1 time daily for the 7
days directly after surgery.
Length of Study Participation:
Participation on the study will be over after participant's routine blood draw 7 days after
surgery.
This is an investigational study.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
Inclusion Criteria:
1. Both pediatric and adult patients can be eligible to participate.
2. Both male and female patients must have a pelvic tumor and are scheduled to have
surgery at UT MD Anderson Cancer center that require hemipelvectomy, resulting in
pelvic ring disruption.
Exclusion Criteria:
1. Patient with a history of genetic prothrombotic state
2. Patient with a history of thromboembolic disease to include pulmonary embolus or other
extremity deep venous thrombosis.
3. Patients with thrombosis of the planned site of resection will not be excluded if the
thrombus is caused directly by tumor burden or outflow obstruction.
4. Female patients will not be eligible for this study if she is either pregnant or
nursing at the time of enrollment.
5. Patients will not be eligible if they have a history of Color vision defects
6. Patients will not be eligible if they have a history of Retinal vein or artery
occlusion
7. Patients will not be eligible if they have a history of Intracranial hemorrhage in
past 6 month.
8. Patients will not be eligible if they have a history of Hypersensitivity to tranexamic
acid
9. Patients will not be eligible if they present with moderate to severe decrease in
creatinine clearance (eGFR < 45 mL/min/1.73m2)
10. Patients will not be eligible if they present or have a history of seizure disorder
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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