Trial Outcomes & Findings for Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty (NCT NCT02569658)

NCT ID: NCT02569658

Last Updated: 2021-11-02

Results Overview

Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 110 participants
• Primary outcome timeframe: Average of 3 days post-operatively
• Results posted on: 2021-11-02

Participant Flow

Participant milestones

Measure	Tranexamic Acid Group Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Overall Study STARTED	53	57
Overall Study COMPLETED	52	56
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Tranexamic Acid Group n=52 Participants Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 Participants Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo	Total n=108 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 10.9 • n=52 Participants	65.2 years STANDARD_DEVIATION 9.2 • n=56 Participants	66.4 years STANDARD_DEVIATION 10 • n=108 Participants
Sex: Female, Male Female	29 Participants n=52 Participants	28 Participants n=56 Participants	57 Participants n=108 Participants
Sex: Female, Male Male	23 Participants n=52 Participants	28 Participants n=56 Participants	51 Participants n=108 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
weight	84.2 kg STANDARD_DEVIATION 19.6 • n=52 Participants	88.4 kg STANDARD_DEVIATION 19.1 • n=56 Participants	86.4 kg STANDARD_DEVIATION 19.3 • n=108 Participants
operative time	101.1 minutes STANDARD_DEVIATION 21.4 • n=52 Participants	102.7 minutes STANDARD_DEVIATION 21.6 • n=56 Participants	101.9 minutes STANDARD_DEVIATION 21.5 • n=108 Participants
reverse total shoulder arthroplasty	29 Participants n=52 Participants	30 Participants n=56 Participants	59 Participants n=108 Participants

PRIMARY outcome

Timeframe: Average of 3 days post-operatively

Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.

Outcome measures

Measure	Tranexamic Acid Group n=52 Participants Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 Participants Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Post-operative Blood Loss	152.2 mL Standard Deviation 57.3	178.0 mL Standard Deviation 65.8

SECONDARY outcome

Timeframe: Average of 3 days post-operatively

Units of pack red blood cells that the patients recieved

Outcome measures

Measure	Tranexamic Acid Group n=52 Participants Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 Participants Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Number of Units Transfused	0 Units of PRBCs	0 Units of PRBCs

SECONDARY outcome

Timeframe: Average of 3 days post-operatively

Patients who received a post-op transfusion of pack red blood cells

Outcome measures

Measure	Tranexamic Acid Group n=52 Participants Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 Participants Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Number of Patients Transfused	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days post-operative

Must be diagnosed via ultrasound duplex

Outcome measures

Measure	Tranexamic Acid Group n=52 Participants Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 Participants Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Number of Participants With Deep Vein Thrombosis	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days post-operative

Must be diagnosed via CT chest or V/Q lung scan

Outcome measures

Measure	Tranexamic Acid Group n=52 Participants Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 Participants Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Number of Participants With Pulmonary Embolism	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days post-operative

Must be diagnosed via CT scan or MRI

Outcome measures

Measure	Tranexamic Acid Group n=52 Participants Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 Participants Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Number of Participants With Stroke	0 Participants	0 Participants

Adverse Events

Tranexamic Acid Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tranexamic Acid Group n=52 participants at risk Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision. Tranexamic Acid	Placebo Group n=56 participants at risk Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision Placebo
Vascular disorders DVT	0.00% 0/52 • 30 days post-operative	1.8% 1/56 • Number of events 1 • 30 days post-operative

Other adverse events

Adverse event data not reported

Additional Information

Yale Fillingham

Rush University Medical Center

Phone: 3095310220

Email: yale.fillingham@gmail.com

Results disclosure agreements

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