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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid group | Active Comparator | 10mg/kg intravenous tranexamic |
|
| Normal Saline group | Placebo Comparator | 10mg/kg intravenous normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | administered prior to surgical incision |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Estimated Blood Loss | Total estimated blood loss in millilitres during the surgery | Average intra operative time 1-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Complications | Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery | at first post-operative visit, 2 weeks post surgery |
| Intra Operative Narcotic Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ettore Vulcano, MD | Ichan School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| Ichan School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26310621 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid Group | 10mg/kg intravenous tranexamic acid administered prior to surgical incision |
| FG001 | Normal Saline Group | 10mg/kg intravenous normal saline administered prior to surgical incision |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid Group | 10mg/kg intravenous tranexamic acid administered prior to surgical incision |
| BG001 | Normal Saline Group | 10mg/kg intravenous normal saline administered prior to surgical incision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Estimated Blood Loss | Total estimated blood loss in millilitres during the surgery | Posted | Mean | Standard Deviation | ml | Average intra operative time 1-2 hours |
|
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid Group | 10mg/kg intravenous tranexamic acid administered prior to surgical incision |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Poonam Pai B. H | Icahn School of Medicine at Mount Sinai | 212-523-4000 | poonam.paibantwalhebbalasankatte@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2017 | Dec 31, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2017 | Dec 31, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000071378 | Bunion |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal saline |
| Drug |
administered prior to surgical incision |
|
Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
| Average intra operative time 1-2 hours |
| Post Operative Narcotic Consumption | Post operative narcotic consumption, morphine mili equivalents | 2 weeks after surgery |
| New York |
| New York |
| 10029 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Wound Complications | Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery | Posted | Count of Participants | Participants | at first post-operative visit, 2 weeks post surgery |
|
|
|
| Secondary | Intra Operative Narcotic Consumption | Total intraoperative narcotic consumption in terms of morphine equivalents.(mme) | Posted | Mean | Standard Deviation | MME | Average intra operative time 1-2 hours |
|
|
|
| Secondary | Post Operative Narcotic Consumption | Post operative narcotic consumption, morphine mili equivalents | Posted | Mean | Standard Deviation | MME | 2 weeks after surgery |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Normal Saline Group | 10mg/kg intravenous normal saline administered prior to surgical incision | 0 | 51 | 0 | 51 | 0 | 51 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |