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Trial record 78 of 419 for:    TRANEXAMIC ACID

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

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ClinicalTrials.gov Identifier: NCT03128866
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Pelvic Mass Procedure: Hemipelvectomy Drug: Tranexamic Acid Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Arm I (tranexamic acid)
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
Undergo hemipelvectomy

Drug: Tranexamic Acid
Given IV
Other Names:
  • Cyclokapron
  • Cyklokapron
  • Lysteda
  • Tranhexamic Acid

Experimental: Arm II (no tranexamic acid)
Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
Procedure: Hemipelvectomy
Undergo hemipelvectomy




Primary Outcome Measures :
  1. Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss [ Time Frame: During first post-operative week ]
    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 :
  1. Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets [ Time Frame: At the time of procedure ]
    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.

  2. Total number of units of PRBCs, FFP, cryoprecipitate, and platelets [ Time Frame: During first post-operative week ]
    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.

  3. Thromboelastography (TEG) [ Time Frame: At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure ]
    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.

  4. Change in laboratory measurements [ Time Frame: Baseline up to 7 days post-surgery ]
    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.

  5. Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding) [ Time Frame: Up to 7 days post-surgery ]
    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.

  6. Length of ICU and hospital stay [ Time Frame: Up to 7 days post-surgery ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128866


Contacts
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Contact: Valerae O. Lewis, MD 713-792-5073 volewis@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Valerae O. Lewis    713-745-4117      
Principal Investigator: Valerae O. Lewis         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Valerae O Lewis M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03128866     History of Changes
Other Study ID Numbers: 2016-0650
NCI-2018-01178 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0650 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants