Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.
Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Active Comparator | The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The TXA group re- ceived a bolus of 10 mg / kg over 15 minutes fol- lowed by an infusion of 1 mg/kg/hr. |
|
| Aminocaproic Acid | Active Comparator | The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The EACA group received a bolus of 100 mg / kg given over 15 minutes shortly after induction of anesthesia followed by an infusion of 10 mg/kg/hr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Infusion during cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Transfusion Amounts | The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2. | 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Gatling, MD | Loma Linda University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | Tranexamic Acid: Infusion during cardiac surgery |
| FG001 | Aminocaproic Acid | Aminocaproic Acid: Infusion during cardiac surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | Tranexamic Acid: Infusion during cardiac surgery |
| BG001 | Aminocaproic Acid | Aminocaproic Acid: Infusion during cardiac surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Transfusion Amounts | The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2. | equality in both arms | Posted | Mean | Standard Deviation | mililiters | 48 hours |
|
|
length of hospital admission, an average of 5 days
adverse events were recorded via review of electronic medical record
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid | Tranexamic Acid: Infusion during cardiac surgery |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Gatling | Loma Linda University Medical Center | 909-558-4475 | 44475 | jgatling@llu.edu |
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D015119 | Aminocaproic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aminocaproic Acid | Drug | Infusion during cardiac surgery |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Aminocaproic Acid | Aminocaproic Acid: Infusion during cardiac surgery | 0 | 42 | 0 | 42 |
Not provided
Not provided
Not provided
| D000614 |
| Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |