Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
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|ClinicalTrials.gov Identifier: NCT03128866|
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Bone and Articular Cartilage Pelvic Tumor||Drug: Tranexamic Acid||Early Phase 1|
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.
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 (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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)|
|Actual Study Start Date :||May 19, 2017|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Tranexamic Acid
Participants receive Tranexamic Acid during hemipelvectomy procedure.
Drug: Tranexamic Acid
No Intervention: No Tranexamic Acid
Participants do not receive Tranexamic Acid during hemipelvectomy procedure.
- Total Perioperative Blood Loss [ Time Frame: During first postoperative week ]Total perioperative blood loss defined as intraoperative estimated blood loss (EBL) plus drain output during 1st postoperative week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128866
|Contact: Valerae O. Lewis, MD, BS||713-745-4117||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Principal Investigator:||Valerae O. Lewis, MD, BS||M.D. Anderson Cancer Center|