Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT03653429
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site: 50
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Foot and Ankle Surgeries; Bunion	Drug: Tranexamic Acid; Drug: Normal saline	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tranexamic acid group 10mg/kg intravenous tranexamic	Drug: Tranexamic Acid; administered prior to surgical incision
Placebo Comparator: Normal Saline group 10mg/kg intravenous normal saline	Drug: Normal saline; administered prior to surgical incision

Outcome Measures

Primary Outcome Measures

1. Total Estimated Blood Loss [Average intra operative time 1-2 hours]

   Total estimated blood loss in millilitres during the surgery

Secondary Outcome Measures

1. 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

2. Intra Operative Narcotic Consumption [Average intra operative time 1-2 hours]

   Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)

3. Post Operative Narcotic Consumption [2 weeks after surgery]

   Post operative narcotic consumption, morphine mili equivalents

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
2	Ichan School of Medicine	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Ettore Vulcano, MD, Ichan School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 23, 2017
• Informed Consent Form - Oct 23, 2017

More Information

Publications

• 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.

• Responsible Party: Yan Lai, Assistant Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03653429
• Other Study ID Numbers: GCO 17-1691
• First Posted: Aug 31, 2018
• Last Update Posted: Apr 29, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yan Lai, Assistant Professor, Icahn School of Medicine at Mount Sinai: foot and ankle surgeries; tranexamic acid; wound healing; blood loss
• Additional relevant MeSH terms: Bunion; Tranexamic Acid

Study Results

Participant Flow

Arm/Group Title	Tranexamic Acid Group	Normal Saline Group
Arm/Group Description	10mg/kg intravenous tranexamic acid administered prior to surgical incision	10mg/kg intravenous normal saline administered prior to surgical incision
Period Title: Overall Study
STARTED	49	51
COMPLETED	45	41
NOT COMPLETED	4	10

Baseline Characteristics

Arm/Group Title	Tranexamic Acid Group	Normal Saline Group	Total
Arm/Group Description	10mg/kg intravenous tranexamic acid administered prior to surgical incision	10mg/kg intravenous normal saline administered prior to surgical incision	Total of all reporting groups
Overall Participants	49	51	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.24 (15.49)	52.51 (14.05)	51.89 (14.71)
Sex: Female, Male (Count of Participants)
Female	31 63.3%	33 64.7%	64 64%
Male	18 36.7%	18 35.3%	36 36%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 10.2%	3 5.9%	8 8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 14.3%	9 17.6%	16 16%
White	37 75.5%	39 76.5%	76 76%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Total Estimated Blood Loss
Description	Total estimated blood loss in millilitres during the surgery
Time Frame	Average intra operative time 1-2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid Group	Normal Saline Group
Arm/Group Description	10mg/kg intravenous tranexamic acid administered prior to surgical incision	10mg/kg intravenous normal saline administered prior to surgical incision
Measure Participants	49	51
Mean (Standard Deviation) [ml]	40.41 (136.78)	18.75 (49.40)

2. Secondary Outcome

Title	Number of Participants With Wound Complications
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid Group	Normal Saline Group
Arm/Group Description	10mg/kg intravenous tranexamic acid administered prior to surgical incision	10mg/kg intravenous normal saline administered prior to surgical incision
Measure Participants	49	51
first post-operative visit	8 16.3%	8 15.7%
2 weeks post surgery	8 16.3%	8 15.7%

3. Secondary Outcome

Title	Intra Operative Narcotic Consumption
Description	Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)
Time Frame	Average intra operative time 1-2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid Group	Normal Saline Group
Arm/Group Description	10mg/kg intravenous tranexamic acid administered prior to surgical incision	10mg/kg intravenous normal saline administered prior to surgical incision
Measure Participants	49	51
Mean (Standard Deviation) [MME]	93.37 (58.80)	125.40 (79.17)

4. Secondary Outcome

Title	Post Operative Narcotic Consumption
Description	Post operative narcotic consumption, morphine mili equivalents
Time Frame	2 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid Group	Normal Saline Group
Arm/Group Description	10mg/kg intravenous tranexamic acid administered prior to surgical incision	10mg/kg intravenous normal saline administered prior to surgical incision
Measure Participants	49	51
Mean (Standard Deviation) [MME]	6.12 (13.32)	10.10 (22.21)

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Tranexamic Acid Group		Normal Saline Group
Arm/Group Description	10mg/kg intravenous tranexamic acid administered prior to surgical incision		10mg/kg intravenous normal saline administered prior to surgical incision
All Cause Mortality
	Tranexamic Acid Group		Normal Saline Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)
Serious Adverse Events
	Tranexamic Acid Group		Normal Saline Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Tranexamic Acid Group		Normal Saline Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.