Cardiopulmonary BypassNCT01248104
Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
A study testing Tranexamic Acid and Aminocaproic Acid in people with Cardiopulmonary Bypass, run by Loma Linda University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Tranexamic Acid and Aminocaproic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is the subject 18 years of age or older?
- Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
- Is the subject more than 30 kg ( 66 lbs)?
- Does subject understand English?
Who cannot join
- Does the subject have existing coagulation defects (INR > 1.5, platelets < 100 ?
- Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
- Does the subject have severe liver disease (AST \& ALT> 3x normal) ?
- Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
- Is the subject having any procedure where CPB is not anticipated?
- Is the patient weight greater than 150 kg?
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Tranexamic Acid, Aminocaproic Acid
- Keywords
- Cardiac Surgery, Antifibrinolytic agents, Blood transfusion, epsilon aminocaproic acid, tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
Infusion during cardiac surgery
Aminocaproic AcidDrug
Also called Amicar
Infusion during cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tranexamic Acid |
| 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. Receives: Drug: Aminocaproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Transfusion Amounts
The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Gatling, MD, Loma Linda University
- Investigators
- Jason Gatling, MD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248104
- Sponsor's protocol ID
- 5100064
- Status last verified
- Sep 2020
- First submitted
- 15 Nov 2010
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01248104
- Acronym / sponsor ID
- 5100064
- Conditions
- Cardiopulmonary Bypass
- Keywords
- Cardiac Surgery, Antifibrinolytic agents, Blood transfusion, epsilon aminocaproic acid, tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Active comparator | Drug: Tranexamic AcidThe 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 | Drug: Aminocaproic AcidThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is the subject 18 years of age or older?
- Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
- Is the subject more than 30 kg ( 66 lbs)?
- Does subject understand English?
Key exclusion criteria (6 listed)
- Does the subject have existing coagulation defects (INR > 1.5, platelets < 100 ?
- Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
- Does the subject have severe liver disease (AST \& ALT> 3x normal) ?
- Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
- Is the subject having any procedure where CPB is not anticipated?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: TXAInfusion during cardiac surgery | Drug | Tranexamic Acid |
| Aminocaproic AcidAlso: AmicarInfusion during cardiac surgery | Drug | Aminocaproic Acid |
Primary outcome
Total Transfusion Amounts
Time frame: 48 hours
The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Bypass
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Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Gatling, MD principal investigator
Loma Linda University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and Aminocaproic Acid in people with Cardiopulmonary Bypass, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Transfusion Amounts (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.