Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure

  • STATUS
    Recruiting
  • End date
    Mar 5, 2025
  • participants needed
    39
  • sponsor
    St. Jude Children's Research Hospital
Updated on 5 January 2021

Summary

This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to decrease blood loss and transfusion requirements in pediatric and young adult cancer patients undergoing a limb salvage procedure that frequently requires perioperative or post-operative transfusions of blood products.

Primary Objective

  • To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg) for patients undergoing limb salvage procedures of the distal femur or proximal tibia who are randomized to receive perioperative tranexamic acid (TXA) versus placebo.

Secondary Objectives

  • To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for patients randomized to receive perioperative TXA versus placebo.
  • To evaluate differences in post-operative daily surgical drain output for patients randomized to receive perioperative TXA versus placebo.
  • To evaluate changes in estimated blood loss (EBL) for patients randomized to receive perioperative TXA versus placebo.
  • To evaluate the association between the intra-or post-operatively transfused blood volume and estimated blood loss (EBL) for patients randomized to receive perioperative TXA and placebo, respectively.

Exploratory Objectives

  • To evaluate differences in functional outcomes post-operatively for patients randomized to receive perioperative TXA versus placebo.
  • To explore if significant correlations are observed between parameters reported with rotational thromboelastometry (ROTEM) and EBL and transfusion requirements in pediatric and young adult patients undergoing limb salvage procedure who are randomized to perioperative TXA versus placebo.
  • To evaluate differences in the prevalence and management of wound complications such as superficial or periprosthetic infections, wound dehiscence, contact dermatitis, postoperative hematomas, or any other clinically significant wound complication between patients randomized to receive perioperative TXA versus placebo.

Description

Eligible participants undergoing limb salvage procedures will be randomized to receive either tranexamic acid (TXA) or placebo peri-operatively.

The initial dose of tranexamic acid/placebo will be given at the initiation of surgical preparation. The second dose will be given 6 hours after the first dose (either intraoperatively or post-operatively). All doses will be given intravenously. Doses will be double blinded and randomized for each surgical procedure.

Details
Treatment 0.9% sodium chloride, Tranexamic Acid
Clinical Study IdentifierNCT04410042
SponsorSt. Jude Children's Research Hospital
Last Modified on5 January 2021

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 24 yrs?
Gender: Male or Female
Do you have any of these conditions: Bone Diseases or Limb Salvage or Bone Neoplasm or Pain; Bone Neoplasms; Neoplasm Metastasis or Bone Cancer?
Do you have any of these conditions: Bone Diseases or Limb Salvage or Bone Cancer or Bone Neoplasm or Pain; Bone Neoplasms; Neoplasm Metastasis?
Do you have any of these conditions: Bone Diseases or Pain; Bone Neoplasms; Neoplasm Metastasis or Bone Neoplasm or Limb Salvage or Bone Cancer?
Do you have any of these conditions: Bone Neoplasm or Pain; Bone Neoplasms; Neoplasm Metastasis or Bone Diseases or Limb Salvage or Bone Cancer?
Do you have any of these conditions: Limb Salvage or Bone Cancer or Pain; Bone Neoplasms; Neoplasm Metastasis or Bone Diseases or Bone Neoplasm?
Do you have any of these conditions: Limb Salvage or Bone Cancer or Pain; Bone Neoplasms; Neoplasm Metastasis or Bone Neoplasm or Bone Diseases?
Participant undergoing limb salvage procedure of malignant bone tumor of the distal femur or proximal tibia, which typically requires blood transfusions
Patient under the age of 25
Adequate bone marrow function defined as
Peripheral absolute neutrophil count (ANC) 1000/mm^3
Platelet count 100,000/mm^3 (transfusion independent defined as no platelets required for 4 days)
Hemoglobin 8.0 g/dL
No RBC transfusion within 24 hours
Adequate renal function defined as
Creatinine clearance or radioisotope GFR 70 mL/min/1.73m^2 OR
Maximum serum creatinine based on age/gender as follows: Age 1 day to < 1 years: maximum serum creatinine (mg/dL) 0.6 for males and 0.5 for females; Age 1 to < 2 years: maximum serum creatinine (mg/dL) 0.6 for males and 0.6 for females; Age 2 to < 6 years: maximum serum creatinine (mg/dL) 0.8 for males and 0.8 for females; Age 6 to < 10 years: maximum serum creatinine (mg/dL) 1.0 for males and 1.0 for females; Age 10 to < 13 years: maximum serum creatinine (mg/dL) 1.2 for males and 1.2 for females; Age 13 to < 16 years: maximum serum creatinine (mg/dL) 1.5 for males and 1.4 for females; Age 16 years: maximum serum creatinine (mg/dL) 1.7 for males and 1.4 for females
Adequate liver function defined as
Total bilirubin 1.5x the institutional upper limit of normal (IULN) for age
ALT (SGPT) and AST (SGOT) 2.5x IULN for age (or <5x IULN for patients with documented disease involving the liver)
Serum albumin > 2 g/dL
Adequate coagulation function as defined by International Normalized Ratio (INR) 1.5
Female participants of child-bearing potential (>10 years old) must have a negative serum or urine pregnancy test within 72 hours of sedation

Exclusion Criteria

Participants whose limb salvage procedure may require significant manipulation of major blood vessels
Participants with known bone marrow deficiency resulting in red blood cell deficiency (e.g. Diamond-Blackfan anemia)
Participants receiving erythropoietin-stimulating agents (e.g. epoetin alfa)
Participants with active hemorrhagic cystitis (e.g. alkylator-induced) with gross hematuria or >50 RBCs per high powered field on urinalysis
Participants actively receiving all-trans retinoic acid (ATRA) or isotretinoin (Accutane)
Participants with known allergies to antifibrinolytics
Participants with known hypercoagulopathies
Personal history of a thrombosis or active thrombus
Participants currently on anticoagulation medications (e.g. warfarin, enoxaparin)
Participants with a history of seizures. Patients with a history of febrile seizure are eligible
Persisting toxicity related to other systemic therapies (e.g. chemotherapy) which constitutes an unacceptable safety risk based on the judgment of the PI and/or the primary treating physician
Female participants who are currently pregnant or actively breastfeeding
Female participants who are currently receiving estrogen-based contraception therapy
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Participants enrolled in another clinical trial utilizing an IND/IDE experimental therapy
Participants with a history of CNS disease
Participants with known bleeding disorder
Participants with known platelet dysfunction
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet