Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Phase 2

Withdrawn

• Conditions: Fracture Humerus
• Interventions: Drug: Tranexamic acid (TXA); Other: Saline

• Registration Number: NCT05802238
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-06
• Study Start: 2023-04-12
• Status Verified: 2024-06
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-25
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Tranexamic acid (TXA)	Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery
Control Group	Saline	The control group will have saline administered 10 minutes prior to surgery.

Primary Outcome Measures

Name	Time	Method
Blood loss	Intraoperatively	The estimated total blood loss measured intraoperatively. This will be done by estimating absorbed drainage by surgical gauze and adding this to total volume in suction canister. Total volume of irrigation used will be subtracted from this total to give an estimate of intraoperative blood loss.

Secondary Outcome Measures

Name	Time	Method
Operative Time	From the start of surgical procedure through the completion of the surgical procedure	Amount of time of operative procedure
Duration of follow-up	Through study completion, an average of one year.	Through study completion, an average of one year.
Complications (DVT, PE, stroke)	through study completion, an average of one year	Presence or absence of the monitored complications (DVT, PE, stroke) will be recorded as a categorical data value.

Trial Locations

Locations (1)

Allegheny Health Network Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States