Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-27 @ 7:27 PM
Study NCT ID:
NCT03128866
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2017-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss.
SECONDARY OBJECTIVES:
I. To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week.
II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7.
III. To determine if use of tranexamic acid has an effect on complication, length of intensive care unit (ICU), and hospital stays.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TRANEXAMIC ACID): Patients receive tranexamic acid intravenously (IV) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.
ARM II (NO TRANEXAMIC ACID): Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 7 days.
I. To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss.
SECONDARY OBJECTIVES:
I. To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week.
II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7.
III. To determine if use of tranexamic acid has an effect on complication, length of intensive care unit (ICU), and hospital stays.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TRANEXAMIC ACID): Patients receive tranexamic acid intravenously (IV) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.
ARM II (NO TRANEXAMIC ACID): Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 7 days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: