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Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started2017-05-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later May 31, 2026 → May 31, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Amendment history

2026-09-25
Primary completion pushed: 2026-05-31 → 2028-05-31
Completion pushed: 2026-05-31 → 2028-05-31
2026-03-03
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2025-09-04
Study Status v14
Re-verified, no change to tracked fields
2025-03-27
Study Identification, Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Tranexamic Acid in Reducing Blood Loss in Patients withWith Pelvic Tumors Undergoing Hemipelvectomy Surgery
2024-09-10
Study Identification, Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Tranexamic Acid in Reducing Blood Loss in Patients Withwith Pelvic Tumors Undergoing Hemipelvectomy Surgery
Show 11 earlier versions
2024-02-21
Study Status, Study Description, Study Design, Eligibility v11
Eligibility criteria+78 characters
Inclusion Criteria: Both pediatric and adult patients can be eligible to participate Cognitively impaired and non-English speakers can be eligible to participate. Both male and female patients must have a pelvic tumor and a [...]
Study description+36 characters
[...] unt of blood products transfused in hemipelvectomy surgeries and during first postoperative week. II. To determine if the use of tranexamic acid has an effe [...]
2023-09-19
Study Status v10
Primary completion date2023-05-31→2026-05-31
Completion date2023-05-31→2026-05-31
2022-10-14
Study Status, References v9
Re-verified, no change to tracked fields
2022-10-13
Study Identification, Study Status v8
Primary completion date2021-05-31→2023-05-31
Completion date2021-05-31→2023-05-31
2020-06-19
Study Status v7
Re-verified, no change to tracked fields
2019-05-20
Study Status, Study Description, Eligibility v6
Eligibility criteria+15 characters
[...] d are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, res [...]
Study description-297 characters
[...] tal stays. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (TRANEXAMIC ACID): Patients will be randomized to receive TXAtranexamic acid intravenously (treatmentIV) or No TXA (control). Arm 1: Those randomized to TXA (treatment): Adult patients and pediatric patients > 40 kg will be given a loading dose of 15 mg/kg 30 min prior to skin incision over 15 minutes followed by a 10 mg/kg/hour maintenance infusion during the surgical procedure. The TXA infusion will be discontinued after wound closure. Pediatric patients (age < 12 and weight 5 - 40 kg) will be given a loading dose of 6.4 mg/kg [...] [...]
2019-05-09
Study Status, Study Description, Eligibility v5
Eligibility criteria-15 characters
[...] d are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, res [...]
Study description+297 characters
[...] tal stays. OUTLINE: Patients are randomized to 1 of 2 arms. ARMPatients Iwill (TRANEXAMICbe ACID):randomized Patientsto receive tranexamic acid intravenouslyTXA (IVtreatment) or No TXA (control). Arm 1: Those randomized to TXA (treatment): Adult patients and pediatric patients > 40 kg will be given a loading dose of 15 mg/kg 30 min prior to skin incision over 15 minutes followed by a 10 mg/kg/hour maintenance infusion during the surgical procedure. The TXA infusion will be discontinued after wound closure. Pediatric patients (age < 12 and weight 5 - 40 kg) will be given a loading dose of 6.4 m [...] [...]
2019-05-07
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2021-05→2021-05-31
Completion date2021-05→2021-05-31
InterventionsTranexamic Acid (Drug)→Hemipelvectomy (Procedure), Tranexamic Acid (Drug)
Eligibility criteria+73 characters
Inclusion Criteria: Both pediatric and adult patients can be eligible to participate. Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption. Exclusion Criteria: Patient with a history of genetic proth [...] pulmonary embolus or other extremity deep venous thrombosis. Patients with thrombosis of the planned site of resection w [...] us is caused directly by tumor burden or outflow obstruction. Female patients will not be eligible for this [...] [...]
Secondary endpoints+431 characters
Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets Total number of units of PRBCs, FFP, cryoprecipitate, and platelets Thromboelastography (TEG) Change in laboratory measurements Complications including but not limited to venous thrombo [...]
Primary endpoints1 entry, revised
Total Perioperativeperioperative Bloodblood Lossloss defined as the total intraoperative estimation of blood (EBL) loss
Study description-168 characters
StudyPRIMARY GroupsOBJECTIVES: IfI. participantTo agreesdetermine toif takethe partuse of tranexamic acid results in thisa study,significant participant will be randomly assigned (asreduction in theintraoperative flipand perioperative blood loss. SECONDARY OBJECTIVES: I. To determine if use of atranexamic coinacid lowers the amount of blood products transfused in hemipelvectomy surgeries. 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 complicat [...] [...]
Study sites1 entry, revised
UniversityM of Texas MDD Anderson Cancer Center
Collaborators+31 characters
National Cancer Institute (NCI)
Study title+23 characters
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
2018-08-10
Study Identification, Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2018-05-25
Study Status v2
Re-verified, no change to tracked fields
2017-05-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2021-06→2021-05
Completion date2021-06→2021-05
Start dateestimated 2017-06→confirmed 2017-05-19
Study sitesdetails revised at 1 of 1 site
2017-04-24
Original filing
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.
Trial Details
NCT Number NCT03128866
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Pelvic Mass
Enrollment 80 participants
Start Date 2017-05-19
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-24