Clinical trial NCT03653429: Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Official title: Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot and Ankle Surgeries
Bunion
Keywords: foot and ankle surgeries
tranexamic acid
wound healing
blood loss
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.

Detailed description: Approximately 20% of all foot and ankle fractures are open. Excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss can increase the risk of infection, hematoma formation and wound complications. Presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses.

Tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. There are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence there is a growing interest in achieving the same operative goals without the use of tourniquet.

Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. It has been effectively used as IV, oral, topical as well as intra articular dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. Reduced bleeding translates to decreased incidence of wound hematoma and other complications.

Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this study is to not only evaluate effectiveness of intravenous TXA in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiology) class I-IV
* age 8-75.

Exclusion Criteria:

* ASA class V
* morbid obesity
* patient refusal
* patients with known coagulopathy disorder
* renal insufficiency
* hepatic dysfunction
* serious cardiac disease
* an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.

Primary outcomes:
measure: Total Estimated Blood Loss
timeFrame: Average intra operative time 1-2 hours
Secondary outcomes:
measure: Number of Participants With Wound Complications
timeFrame: at first post-operative visit, 2 weeks post surgery
measure: Intra Operative Narcotic Consumption
timeFrame: Average intra operative time 1-2 hours
measure: Post Operative Narcotic Consumption
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Ichan School of Medicine
state: New York
Study officials:
affiliation: Ichan School of Medicine
name: Ettore Vulcano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xie B, Tian J, Zhou DP. Administration of Tranexamic Acid Reduces Postoperative Blood Loss in Calcaneal Fractures: A Randomized Controlled Trial. J Foot Ankle Surg. 2015 Nov-Dec;54(6):1106-10. doi: 10.1053/j.jfas.2015.07.006. Epub 2015 Aug 24.