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

Primary Purpose

Pelvic Mass

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hemipelvectomy

Tranexamic Acid

About this trial

This is an interventional treatment trial for Pelvic Mass

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I (tranexamic acid)

Arm II (no tranexamic acid)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of intense care unit (ICU), and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

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

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Thromboelastography (TEG)

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Change in laboratory measurements

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

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

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Length of ICU and hospital stay

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Full Information

NCT ID

NCT03128866

First Posted

April 21, 2017

Last Updated

September 19, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03128866

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 19, 2017 (Actual)

Primary Completion Date

May 31, 2026 (Anticipated)

Study Completion Date

May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Mass

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (tranexamic acid)

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm II (no tranexamic acid)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Hemipelvectomy

Intervention Description

Undergo hemipelvectomy

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Other Intervention Name(s)

Cyclokapron, Cyklokapron, Lysteda, Tranhexamic Acid

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

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

Description

Time Frame

During first post-operative week

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

At the time of procedure

Title

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

Description

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Time Frame

During first post-operative week

Title

Thromboelastography (TEG)

Description

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Time Frame

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

Title

Change in laboratory measurements

Description

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Time Frame

Baseline up to 7 days post-surgery

Title

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

Description

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Time Frame

Up to 7 days post-surgery

Title

Length of ICU and hospital stay

Description

Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.

Time Frame

Up to 7 days post-surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valerae O. Lewis, MD

Phone

713-792-5073

volewis@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valerae O Lewis

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valerae O. Lewis

Phone

713-745-4117

First Name & Middle Initial & Last Name & Degree

Valerae O. Lewis

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center

Learn more about this trial

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

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