Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Allegheny Health Network (AHN)

Status and phase: Withdrawn; Phase 2

Conditions: Fracture Humerus

Treatments: Drug: Tranexamic acid (TXA); Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05802238

2021-153

Details and patient eligibility

About

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

Full description

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females age 18-100 years
2. Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation.
3. Must be able to read and understand English and consent for themselves.

Exclusion criteria

1. Allergy to TXA.
2. Acquired disturbances of color vision.
3. History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA.
4. Pregnant or breastfeeding.
5. Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement.
6. Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men)
7. Refusal of blood products
8. Subarachnoid hemorrhage
9. Disseminated intravascular coagulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Description:

Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery

Treatment:

Drug: Tranexamic acid (TXA)

Control Group

Placebo Comparator group

Description:

The control group will have saline administered 10 minutes prior to surgery.

Treatment:

Other: Saline