Trial Outcomes & Findings for Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty (NCT NCT01370460)

Results Overview

Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

101 participants

Primary outcome timeframe

participants will be followed for the duration of hospital stay, an expected average of 3 days

Results posted on

2023-04-25

Participant Flow

We planned on 50 patients in one treatment arm and 51 in another, resulting in 101 overall patients.

Participant milestones

Participant milestones
Measure	Tranexamic Acid Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.	Placebo 100mL 0.9% NS, applied topically
Overall Study STARTED	50	51
Overall Study COMPLETED	50	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tranexamic Acid n=50 Participants Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.	Placebo n=51 Participants 100mL 0.9% NS, applied topically	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	26 Participants n=4 Participants	51 Participants n=27 Participants
Age, Categorical >=65 years	25 Participants n=93 Participants	25 Participants n=4 Participants	50 Participants n=27 Participants
Age, Continuous	67 years STANDARD_DEVIATION 9 • n=93 Participants	64.5 years STANDARD_DEVIATION 8.2 • n=4 Participants	65.75 years STANDARD_DEVIATION 8.6 • n=27 Participants
Sex: Female, Male Female	31 Participants n=93 Participants	39 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	12 Participants n=4 Participants	31 Participants n=27 Participants
Region of Enrollment United States	50 participants n=93 Participants	51 participants n=4 Participants	101 participants n=27 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants 100mL 0.9% NS, applied topically	Tranexamic Acid n=50 Participants Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
Blood Loss	1293.1 mL Standard Deviation 532.7	940.2 mL Standard Deviation 327.1

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of \< 8.0g/dL hemoglobin, or any hemoglobin \<7.0 g/dL, precipitated transfusion.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants 100mL 0.9% NS, applied topically	Tranexamic Acid n=51 Participants Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
Postoperative Transfusion Rate	0 participants	4 participants

Adverse Events

Adverse Events Not Collected

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

Andrew Georgiadis, MD

Henry Ford Health System

Phone: 313-916-7520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place