Trial Outcomes & Findings for Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery (NCT NCT01248104)

NCT ID: NCT01248104

Last Updated: 2020-10-19

Results Overview

The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2020-10-19

Participant Flow

Adult patients scheduled for primary cardiac surgery utilizing CPB at LLUMC . Subjects myst be >30 kg, be able to understand English, and sign the consent form.Subjects will be recruited in the pre-admitting area prior to going to the PDCU area in the operating room.

Participant milestones

Measure	Tranexamic Acid Tranexamic Acid: Infusion during cardiac surgery	Aminocaproic Acid Aminocaproic Acid: Infusion during cardiac surgery
Overall Study STARTED	50	50
Overall Study COMPLETED	40	42
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery

Baseline characteristics by cohort

Measure	Tranexamic Acid n=40 Participants Tranexamic Acid: Infusion during cardiac surgery	Aminocaproic Acid n=42 Participants Aminocaproic Acid: Infusion during cardiac surgery	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Continuous	63.79175 years STANDARD_DEVIATION 13.1260508 • n=5 Participants	63.25333 years STANDARD_DEVIATION 12.62622 • n=7 Participants	63.51597561 years STANDARD_DEVIATION 12.79547179 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: equality in both arms

The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.

Outcome measures

Measure	Tranexamic Acid n=40 Participants Tranexamic Acid: Infusion during cardiac surgery	Aminocaproic Acid n=42 Participants Aminocaproic Acid: Infusion during cardiac surgery
Total Transfusion Amounts	161 mililiters Standard Deviation 274	116 mililiters Standard Deviation 296

Adverse Events

Tranexamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aminocaproic Acid

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. Jason Gatling

Loma Linda University Medical Center

Phone: 909-558-4475

Email: jgatling@llu.edu

Results disclosure agreements

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