Aortic DiseaseEarly Phase 1EACANCT01965730
Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery
A Early Phase 1 study testing epsilon-aminocaproic acid (EACA) in people with Aortic Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Disease
- What is being tested?
- epsilon-aminocaproic acid (EACA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to sign informed consent
- Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest
Who cannot join
- Inability to sign informed consent
- Baseline hypercoagulable condition as defined in medical record
- Coronary disease with untreated lesions or recent coronary stent placement
- Severe renal dysfunction (ESRD) as documented in medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography
This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events
- Conditions
- Aortic Disease
- Being tested
- epsilon-aminocaproic acid (EACA)
- Keywords
- dilated ascending aorta
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epsilon-aminocaproic acid (EACA)Drug
Also called Amicar
| Study group | Role | What they receive |
|---|---|---|
| epsilon-aminocaproic acid (EACA) | Active comparator | 75mg/kg loading dose with infusion 15mg/kg/hr Receives: Drug: epsilon-aminocaproic acid (EACA) |
| EACA | Experimental | 125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery. Receives: Drug: epsilon-aminocaproic acid (EACA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of fibrinolysis as measured by thromboelastography
The primary objective of the study will be to determine if a change in EACA dosing for cardiac surgery cases involving circulatory arrest actually leads to a quantifiable change in the degree of fibrinolysis as measured by TEG.
Measured: Length of cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: the study was suspended due to shortage of the study drug (amicar).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prakash A Patel, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965730
- Sponsor's protocol ID
- 816724
- Acronym
- EACA
- Status last verified
- Apr 2019
- First submitted
- 16 Oct 2013
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography
- ClinicalTrials.gov ID
- NCT01965730
- Acronym / sponsor ID
- EACA / 816724
- Conditions
- Aortic Disease
- Keywords
- dilated ascending aorta
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was suspended due to shortage of the study drug (amicar).
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epsilon-aminocaproic acid (EACA) | Active comparator | Drug: epsilon-aminocaproic acid (EACA)75mg/kg loading dose with infusion 15mg/kg/hr |
| EACA | Experimental | Drug: epsilon-aminocaproic acid (EACA)125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to sign informed consent
- Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest
Key exclusion criteria (4 listed)
- Inability to sign informed consent
- Baseline hypercoagulable condition as defined in medical record
- Coronary disease with untreated lesions or recent coronary stent placement
- Severe renal dysfunction (ESRD) as documented in medical record
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 |
|---|---|---|
| epsilon-aminocaproic acid (EACA)Also: Amicar | Drug | EACA, epsilon-aminocaproic acid (EACA) |
Primary outcome
degree of fibrinolysis as measured by thromboelastography
Time frame: Length of cardiac surgery
The primary objective of the study will be to determine if a change in EACA dosing for cardiac surgery cases involving circulatory arrest actually leads to a quantifiable change in the degree of fibrinolysis as measured by TEG.
Results and safety
The study was stopped early (reason given: the study was suspended due to shortage of the study drug (amicar).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
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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.
Prakash A Patel, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing epsilon-aminocaproic acid (EACA) in people with Aortic Disease, run by University of Pennsylvania 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 May 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the study was suspended due to shortage of the study drug (amicar).). Results are not available in the source record.
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?
degree of fibrinolysis as measured by thromboelastography (time frame: Length of cardiac surgery). 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 2 May 2019.