Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures

NCT01727843 | Terminated Phase 3 DMC

• 2 other identifiers: SURG-263-126007434
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However, concerns about the prothrombotic side effects of systemic administration of TA has hindered the widespread adoption of this medication in orthopaedic patients due to their high risk for thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical application of tranexamic acid has been proposed as a way to mitigate the potential prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following topical application, minimizing its potential systemic thromboembolic side effects. TA has been used topically in total knee arthroplasty, with significant reductions in blood loss and no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture surgery is limited, and there are no studies examining topical use of TA in hip fracture surgery.

Conditions

Femoral Neck Fracture

Keywords

fracture; hip; tranexamic acid; topical

Outcome Measures

Primary Outcomes (1)

• Blood loss

  postop 0-8 days.

Study Arms (2)

tranexamic acid

EXPERIMENTAL

3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.

Drug: Tranexamic Acid

saline

PLACEBO COMPARATOR

3000mg/mL saline applied directly to the wound at the end of the surgical procedure

Other: placebo

Interventions

Tranexamic Acid DRUG

drug and placebo applied topically at end of surgery at hip site.

Also known as: Cyklokapron

tranexamic acid

placebo OTHER

applied topically to surgical site in OR.

Also known as: saline solution

saline

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• hip fracture patients
• aged 65 and older.

You may not qualify if:

• bilateral femoral neck fracture patient and/or one that is not suited to a hemiarthroplasty repair.

Sponsors & Collaborators

• Dr. Jeff Yach: lead

Study Sites (1)

Queen's Univeristy, KGH

Kingston, Ontario, K7L2G7, Canada

Location

MeSH Terms

Conditions

Femoral Neck Fractures; Fractures, Bone

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jeff Yach, MD

  Queen's Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 16, 2012
• Study Start: April 1, 2013
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

CA (1)