Clinical trial NCT03128866: Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery
Official title: Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pelvic Mass
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-25
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 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 prothrombotic state
* Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis
* 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
* Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment
* Patients will not be eligible if they have a history of color vision defects
* Patients will not be eligible if they have a history of retinal vein or artery occlusion
* Patients will not be eligible if they have a history of intracranial hemorrhage in past 6 months
* Patients will not be eligible if they have a history of hypersensitivity to tranexamic acid
* Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate \[eGFR\] \< 45 mL/min/1.73m2)
* Patients will not be eligible if they present or have a history of seizure disorder

Primary outcomes:
measure: Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss
timeFrame: During first post-operative week
Secondary outcomes:
measure: Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets
timeFrame: At the time of procedure
measure: Total number of units of PRBCs, FFP, cryoprecipitate, and platelets
timeFrame: During first post-operative week
measure: Thromboelastography (TEG)
timeFrame: At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure
measure: Change in laboratory measurements
timeFrame: Baseline up to 7 days post-surgery
measure: Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)
timeFrame: Up to 7 days post-surgery
measure: Length of ICU and hospital stay
timeFrame: Up to 7 days post-surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Valerae O Lewis
role: PRINCIPAL_INVESTIGATOR
References: