Trial Outcomes & Findings for Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement (NCT NCT03182751)

NCT ID: NCT03182751

Last Updated: 2023-03-30

Results Overview

Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 128 participants
• Primary outcome timeframe: Length of hospitalization (approximately 3 to 5 days)
• Results posted on: 2023-03-30

Participant Flow

Participant milestones

Measure	Tranexamic Acid Arm (TXA) Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Overall Study STARTED	64	64
Overall Study COMPLETED	64	64
Overall Study NOT COMPLETED	0	0

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 Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient	Total n=128 Participants Total of all reporting groups
Age, Continuous	79.1 years STANDARD_DEVIATION 13.5 • n=64 Participants	79.69 years STANDARD_DEVIATION 12.7 • n=64 Participants	79.39 years STANDARD_DEVIATION 13.1 • n=128 Participants
Sex: Female, Male Female	45 Participants n=64 Participants	45 Participants n=64 Participants	90 Participants n=128 Participants
Sex: Female, Male Male	19 Participants n=64 Participants	19 Participants n=64 Participants	38 Participants n=128 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	64 participants n=64 Participants	64 participants n=64 Participants	128 participants n=128 Participants

PRIMARY outcome

Timeframe: Length of hospitalization (approximately 3 to 5 days)

Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells	17 Participants	19 Participants

SECONDARY outcome

Timeframe: Length of hospitalization (approximately 3 to 5 days)

Number of units of packed red blood cells transfused per patient

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=17 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=19 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Number of Units of Packed Red Blood Cells Transfused	1.9 units of packed red blood cells Standard Deviation 1.9	2.3 units of packed red blood cells Standard Deviation 1.7

SECONDARY outcome

Timeframe: Length of hospitalization (approximately 3 to 5 days)

Total blood loss per patient measured in milliliters (mL)

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Calculated Blood Loss	1600 mL Standard Deviation 1200	2000 mL Standard Deviation 1400

SECONDARY outcome

Timeframe: Within 6 months of surgery

Number of subjects to experience symptomatic Venous Thromboembolism (VTE)

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 6 months of surgery

Number of subjects diagnosed with a wound complication

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Wound Complications	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 6 months of surgery

Number of subjects diagnosed with a myocardial infarction

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
(Myocardial Infarction) MI Diagnosed	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 6 months of surgery

Number of subjects diagnosed with a cerebrovascular accident

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Cerebrovascular Accident (CVA) Diagnosed	0 Participants	3 Participants

SECONDARY outcome

Timeframe: At 6 months after surgery

Number of subject deaths

Outcome measures

Measure	Tranexamic Acid Arm (TXA) n=64 Participants Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 Participants Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
All-cause Mortality	7 Participants	6 Participants

Adverse Events

Tranexamic Acid Arm (TXA)

Serious events: 8 serious events

Other events: 0 other events

Deaths: 7 deaths

Control Arm

Serious events: 7 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Measure	Tranexamic Acid Arm (TXA) n=64 participants at risk Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours	Control Arm n=64 participants at risk Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient
Vascular disorders Deep Vein Thrombosis (DVT)	4.7% 3/64 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.	1.6% 1/64 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism (PE)	1.6% 1/64 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.	0.00% 0/64 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.
Nervous system disorders Stroke	0.00% 0/64 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.	4.7% 3/64 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.
Cardiac disorders Myocardial Infarction	0.00% 0/64 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.	3.1% 2/64 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.
Surgical and medical procedures Wound Complication	6.2% 4/64 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.	1.6% 1/64 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brandon Yuan

Mayo Clinic

Phone: 507-255-6112

Email: Yuan.Brandon@mayo.edu

Results disclosure agreements

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