ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 110 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Neoplasms"

Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03128866
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to determine if tranexamic acid can help in reduction of blood and blood product loss before, during, and after surgery.

Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Bone and Articular Cartilage Pelvic Tumor Drug: Tranexamic Acid Early Phase 1

Detailed Description:

Study Groups:

If participant agrees to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being assigned to either group.

During surgery, one group will receive the study drug by vein and the other group will not.

The study staff and surgeons will know if participant is receiving the study drug or not.

Surgery:

Participant will have participant's surgery as planned. Participant will sign a separate consent for the surgery that explains the procedure and the risks.

Medical Information Collection:

Researchers will collect information from participant's medical record before, during, and after the surgery for this study.

Blood Draws:

Blood (about 2-4 teaspoons each time) will be drawn for routine tests 1 time daily for the 7 days directly after surgery.

Length of Study Participation:

Participation on the study will be over after participant's routine blood draw 7 days after surgery.

This is an investigational study.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.


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 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Tranexamic Acid
Participants receive Tranexamic Acid during hemipelvectomy procedure.
Drug: Tranexamic Acid
  1. Adult patients and pediatric patients > 40 kg 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. TXA infusion discontinued after wound closure.
  2. Pediatric patients (age < 12 and weight 5 - 40 kg) given a loading dose of 6.4 mg/kg (maximum 1 gram) dose 30 minutes prior to skin incision over 15 minutes, followed by 2 - 3.1 mg/kg/hr maintenance infusion until skin closure.

No Intervention: No Tranexamic Acid
Participants do not receive Tranexamic Acid during hemipelvectomy procedure.



Primary Outcome Measures :
  1. Total Perioperative Blood Loss [ Time Frame: During first postoperative week ]
    Total perioperative blood loss defined as intraoperative estimated blood loss (EBL) plus drain output during 1st postoperative week.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Both pediatric and adult patients can be eligible to participate.
  2. Both male and female patients must have a pelvic tumor and are scheduled to have surgery at UT MD Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption.

Exclusion Criteria:

  1. Patient with a history of genetic prothrombotic state
  2. Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis.
  3. 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.
  4. Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment.
  5. Patients will not be eligible if they have a history of Color vision defects
  6. Patients will not be eligible if they have a history of Retinal vein or artery occlusion
  7. Patients will not be eligible if they have a history of Intracranial hemorrhage in past 6 month.
  8. Patients will not be eligible if they have a history of Hypersensitivity to tranexamic acid
  9. Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (eGFR < 45 mL/min/1.73m2)
  10. 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
Contact: Bryan S. Moon, MD 713-745-4117 bsmoon@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       bsmoon@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Bryan S. Moon, MD M.D. Anderson Cancer Center

Additional Information:
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: NCI CTRP )
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of bone and articular cartilage
Pelvic Tumor
Tranexamic acid

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms
Cartilage Diseases
Soft Tissue Neoplasms
Neoplasms, Fibrous Tissue
Pelvic Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants