Bunion, Foot and Ankle Surgeries
Conditions
Keywords
foot and ankle surgeries, tranexamic acid, wound healing, blood loss
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.
Interventions
DRUGTranexamic Acid
administered prior to surgical incision
DRUGNormal saline
administered prior to surgical incision
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Estimated Blood Loss | Average intra operative time 1-2 hours | Total estimated blood loss in millilitres during the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Complications | at first post-operative visit, 2 weeks post surgery | Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery |
| Intra Operative Narcotic Consumption | Average intra operative time 1-2 hours | Total intraoperative narcotic consumption in terms of morphine equivalents.(mme) |
| Post Operative Narcotic Consumption | 2 weeks after surgery | Post operative narcotic consumption, morphine mili equivalents |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Group 10mg/kg intravenous tranexamic acid administered prior to surgical incision | 49 |
| Normal Saline Group 10mg/kg intravenous normal saline administered prior to surgical incision | 51 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 4 | 10 |
Baseline characteristics
| Characteristic | Normal Saline Group | Total | Tranexamic Acid Group |
|---|---|---|---|
| Age, Continuous | 52.51 years STANDARD_DEVIATION 14.05 | 51.89 years STANDARD_DEVIATION 14.71 | 51.24 years STANDARD_DEVIATION 15.49 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 76 Participants | 37 Participants |
| Sex: Female, Male Female | 33 Participants | 64 Participants | 31 Participants |
| Sex: Female, Male Male | 18 Participants | 36 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
Primary
Total Estimated Blood Loss
Total estimated blood loss in millilitres during the surgery
Time frame: Average intra operative time 1-2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Group | Total Estimated Blood Loss | 40.41 ml | Standard Deviation 136.78 |
| Normal Saline Group | Total Estimated Blood Loss | 18.75 ml | Standard Deviation 49.4 |
Secondary
Intra Operative Narcotic Consumption
Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
Time frame: Average intra operative time 1-2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Group | Intra Operative Narcotic Consumption | 93.37 MME | Standard Deviation 58.8 |
| Normal Saline Group | Intra Operative Narcotic Consumption | 125.40 MME | Standard Deviation 79.17 |
Secondary
Number of Participants With Wound Complications
Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery
Time frame: at first post-operative visit, 2 weeks post surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tranexamic Acid Group | Number of Participants With Wound Complications | first post-operative visit | 8 Participants |
| Tranexamic Acid Group | Number of Participants With Wound Complications | 2 weeks post surgery | 8 Participants |
| Normal Saline Group | Number of Participants With Wound Complications | first post-operative visit | 8 Participants |
| Normal Saline Group | Number of Participants With Wound Complications | 2 weeks post surgery | 8 Participants |
Secondary
Post Operative Narcotic Consumption
Post operative narcotic consumption, morphine mili equivalents
Time frame: 2 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Group | Post Operative Narcotic Consumption | 6.12 MME | Standard Deviation 13.32 |
| Normal Saline Group | Post Operative Narcotic Consumption | 10.10 MME | Standard Deviation 22.21 |