TXA Study in Major Burn Surgery

S

Spectrum Health Hospitals

Status

Terminated

Conditions

Major Surgery
Tranexamic Acid
Burn

Treatments

Drug: Tranexamic Acid
Drug: Placebo Comparator

Study type

Interventional

Funder types

Other

Identifiers

NCT02753816
2015-154

Details and patient eligibility

About

Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your stay. In this study, prior to each surgical procedure to treat the participants burn injury, the participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid that looks like the tranexamic acid medicine, but does not have any active ingredient in it. In this study, both the tranexamic acid and the placebo are considered research.

Full description

Neither the participant nor the study doctor will choose what treatment the participant gets. The participant will have an equal chance of being given the tranexamic acid or the placebo. Neither the participant nor the study doctor will know which treatment the participant is receiving. The participant will receive one 1 gram dose of either tranexamic acid or placebo immediately before surgery. The dose of tranexamic acid or placebo will be given in the participants vein over a 10-minute period. Information from the participants medical record related to their surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with the participants study number instead of their name.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects undergoing burn excision surgery for standard of care purposes (to include: greater than or equal to 350 cm2 of full thickness or deep partial thickness burns)
  • Male or female > 18 years of age
  • Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Exclusion criteria

  • Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
  • Baseline creatinine level greater than 2.83 mg/dL
  • Subjects with known hypersensitivity to tranexamic acid
  • Patients with acquired defective color vision
  • Patients with subarachnoid hemorrhage
  • Children
  • Pregnant women
  • Prisoners

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

25 participants in 2 patient groups, including a placebo group

Tranexamic Acid
Experimental group
Description:
1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery
Treatment:
Drug: Tranexamic Acid
Placebo
Placebo Comparator group
Description:
Placebo given over 10 minutes into the vein once prior to surgery
Treatment:
Drug: Placebo Comparator

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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