Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

NCT05802238 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 2021-153
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Humerus

Keywords

Open Reduction Internal Fixation; Blood loss

Outcome Measures

Primary Outcomes (1)

• Blood loss

  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.

  Intraoperatively

Secondary Outcomes (3)

• Operative Time

  From the start of surgical procedure through the completion of the surgical procedure

• Duration of follow-up

  Through study completion, an average of one year.

• Complications (DVT, PE, stroke)

  through study completion, an average of one year

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Drug: Tranexamic acid (TXA)

Control Group

PLACEBO COMPARATOR

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

Other: Saline

Interventions

Tranexamic acid (TXA) DRUG

1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery

Also known as: Tranexamic acid

Treatment Arm

Saline OTHER

control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny Health Network Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Humeral Fractures; Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Peter Tang, MD

  Allegheny Health Network Allegheny General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Model Details: Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: April 6, 2023
• Study Start: April 12, 2023
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-06

Locations

US (1)