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

NCT03128866 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2016-0650NCI-2018-01178
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Mass

Outcome Measures

Primary Outcomes (1)

• Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss

  Intraoperative blood loss and perioperative blood loss (total of intraoperative EBL and 1 week drain) will be compared between two groups utilizing two-sample t-test or Wilcoxon rank-sum test. Log-transformation will be taken on the blood loss measurements as appropriate. Multivariable linear regression models will be used to compare two treatment groups in intraoperative and perioperative blood loss by adjusting for significant covariates. Model selection technique, including backward elimination, will be implemented.

  During first post-operative week

Secondary Outcomes (6)

• Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets

  At the time of procedure

• Total number of units of PRBCs, FFP, cryoprecipitate, and platelets

  During first post-operative week

• Thromboelastography (TEG)

  At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure

• Change in laboratory measurements

  Baseline up to 7 days post-surgery

• Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)

  Up to 7 days post-surgery

Study Arms (2)

Arm I (tranexamic acid)

EXPERIMENTAL

Patients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.

Procedure: Hemipelvectomy; Drug: Tranexamic Acid

Arm II (no tranexamic acid)

EXPERIMENTAL

Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.

Procedure: Hemipelvectomy

Interventions

Hemipelvectomy PROCEDURE

Undergo hemipelvectomy

Arm I (tranexamic acid); Arm II (no tranexamic acid)

Tranexamic Acid DRUG

Given IV

Also known as: Cyclokapron, Cyklokapron, Lysteda, Tranhexamic Acid

Arm I (tranexamic acid)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Hemipelvectomy; Tranexamic Acid

Intervention Hierarchy (Ancestors)

Amputation, Surgical; Orthopedic Procedures; Surgical Procedures, Operative; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Valerae O Lewis

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 25, 2017
• Study Start: May 19, 2017
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2025-09

Locations

US (1)