Clinical trial NCT01727843: Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures
Official title: Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Femoral Neck Fracture
Keywords: fracture
hip
tranexamic acid
topical
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Our study question is: Does topical tranexamic acid decrease blood loss following hemiarthroplasty of the hip for femoral neck fractures? The type of information collected by the research assistant will consist of estimated blood loss during surgery, length of stay in hospital, any wound infections as well as any thromboembolic side effects (blood clots in legs and/or heart) that may occur. The number of units of red blood cells transfused will be recorded up to and including postoperative day 8. Preoperative hemoglobin and lowest postoperative hemoglobin levels up to and including post-op day 8 will also be collected as well as any use of ambulatory aids will be recorded on presentation to hospital, discharge and 6 weeks post operatively.

Eligibility criteria: Inclusion Criteria:

* hip fracture patients
* aged 65 and older.

Exclusion Criteria:

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

Primary outcomes:
measure: Blood loss
timeFrame: postop 0-8 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's Univeristy, KGH
state: Ontario
Study officials:
affiliation: Queen's Univeristy
name: Jeff Yach, MD
role: PRINCIPAL_INVESTIGATOR
References: