Trial Outcomes & Findings for Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty (NCT NCT03825939)

Results Overview

Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

operative period (average of 1 hour)

Results posted on

2021-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Tranexamic Acid * 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery Intravenous Tranexamic Acid: 1g TXA IVPB	Intravenous Placebo \- IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline	Intravenous Tranexamic Acid Followed by Intravenous Placebo * 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery * IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline Intravenous Tranexamic Acid: 1g TXA IVPB
Overall Study STARTED	18	20	14
Overall Study COMPLETED	18	20	14
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Tranexamic Acid n=18 Participants * 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery Intravenous Tranexamic Acid: 1g TXA IVPB	Intravenous Placebo n=20 Participants \- IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline	Intravenous Tranexamic Acid Followed by Intravenous Placebo n=14 Participants * 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery * IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline Intravenous Tranexamic Acid: 1g TXA IVPB	Total n=52 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 6 • n=5 Participants	67.2 years STANDARD_DEVIATION 11.4 • n=7 Participants	65.2 years STANDARD_DEVIATION 12.3 • n=5 Participants	65.6 years STANDARD_DEVIATION 10.1 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	46 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Pre-operative hemoglobin	14.4 grams/decileter (g/dl) STANDARD_DEVIATION 1.5 • n=5 Participants	13.6 grams/decileter (g/dl) STANDARD_DEVIATION 1.4 • n=7 Participants	13.8 grams/decileter (g/dl) STANDARD_DEVIATION 1.5 • n=5 Participants	13.9 grams/decileter (g/dl) STANDARD_DEVIATION 1.5 • n=4 Participants
Pre-operative hematocrit	43.6 percentage of red blood cells STANDARD_DEVIATION 4.6 • n=5 Participants	41.2 percentage of red blood cells STANDARD_DEVIATION 4.2 • n=7 Participants	41.2 percentage of red blood cells STANDARD_DEVIATION 4.3 • n=5 Participants	42.0 percentage of red blood cells STANDARD_DEVIATION 4.5 • n=4 Participants

PRIMARY outcome

Timeframe: operative period (average of 1 hour)

Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 3 or 4 post surgery

Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Hospital Discharge

Measured in Days

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=18 Participants * 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery Intravenous Tranexamic Acid: 1g TXA IVPB	Intravenous Placebo n=20 Participants \- IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline	Intravenous Tranexamic Acid Followed by Intravenous Placebo n=14 Participants * 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery * IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline Intravenous Tranexamic Acid: 1g TXA IVPB
Length of Hospital Stay	3 Days Interval 3.0 to 3.0	3 Days Interval 2.5 to 3.0	3 Days Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Operative period (an average of 1 hour)

Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Surgeon estimated blood loss

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 3 or 4 post surgery

Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Measured in grams/deciliter

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 Days

Population: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Walking distance (feet) will be assessed and documented throughout the hospital stay

Outcome measures

Outcome data not reported

Adverse Events

Intravenous Tranexamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Tranexamic Acid Followed by Intravenous Placebo

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

Dr. Jan Koenig

NYU Langone

Phone: 516-678-2232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place