Trial Outcomes & Findings for Efficacy of Tranexamic Acid in Foot and Ankle Surgeries (NCT NCT03653429)

NCT ID: NCT03653429

Last Updated: 2020-04-29

Results Overview

Total estimated blood loss in millilitres during the surgery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: Average intra operative time 1-2 hours
• Results posted on: 2020-04-29

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Tranexamic Acid Group 10mg/kg intravenous tranexamic acid administered prior to surgical incision	Normal Saline Group 10mg/kg intravenous normal saline administered prior to surgical incision
Overall Study Physician Decision	4	10

Baseline Characteristics

Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Baseline characteristics by cohort

Measure	Tranexamic Acid Group n=49 Participants 10mg/kg intravenous tranexamic acid administered prior to surgical incision	Normal Saline Group n=51 Participants 10mg/kg intravenous normal saline administered prior to surgical incision	Total n=100 Participants Total of all reporting groups
Age, Continuous	51.24 years STANDARD_DEVIATION 15.49 • n=5 Participants	52.51 years STANDARD_DEVIATION 14.05 • n=7 Participants	51.89 years STANDARD_DEVIATION 14.71 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Average intra operative time 1-2 hours

Total estimated blood loss in millilitres during the surgery

Outcome measures

Measure	Tranexamic Acid Group n=49 Participants 10mg/kg intravenous tranexamic acid administered prior to surgical incision	Normal Saline Group n=51 Participants 10mg/kg intravenous normal saline administered prior to surgical incision
Total Estimated Blood Loss	40.41 ml Standard Deviation 136.78	18.75 ml Standard Deviation 49.40

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Tranexamic Acid Group n=49 Participants 10mg/kg intravenous tranexamic acid administered prior to surgical incision	Normal Saline Group n=51 Participants 10mg/kg intravenous normal saline administered prior to surgical incision
Number of Participants With Wound Complications first post-operative visit	8 Participants	8 Participants
Number of Participants With Wound Complications 2 weeks post surgery	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Average intra operative time 1-2 hours

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

Outcome measures

Measure	Tranexamic Acid Group n=49 Participants 10mg/kg intravenous tranexamic acid administered prior to surgical incision	Normal Saline Group n=51 Participants 10mg/kg intravenous normal saline administered prior to surgical incision
Intra Operative Narcotic Consumption	93.37 MME Standard Deviation 58.80	125.40 MME Standard Deviation 79.17

SECONDARY outcome

Timeframe: 2 weeks after surgery

Post operative narcotic consumption, morphine mili equivalents

Outcome measures

Measure	Tranexamic Acid Group n=49 Participants 10mg/kg intravenous tranexamic acid administered prior to surgical incision	Normal Saline Group n=51 Participants 10mg/kg intravenous normal saline administered prior to surgical incision
Post Operative Narcotic Consumption	6.12 MME Standard Deviation 13.32	10.10 MME Standard Deviation 22.21

Adverse Events

Tranexamic Acid Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Poonam Pai B. H

Icahn School of Medicine at Mount Sinai

Phone: 212-523-4000

Email: poonam.paibantwalhebbalasankatte@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place