Cardiac Surgery-CABGPhase 1/2EPORTNCT02802592
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
A Phase 1/2 study testing Epogen and Normal Saline in people with Cardiac Surgery-CABG and Cardiac Valve Replacement, run by Johns Hopkins University at 1 site in United States.
Trial summary
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT) Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cardiac Surgery-CABG, Cardiac Valve Replacement
- What is being tested?
- Epogen and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 27 Feb 2017
- Phase
- Phase 1/2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be male or female and 18 years of age or older, but less than 65 years of age
- Be willing to performed written informed consent prior to study initiation
- Be willing and able to comply with the protocol for study duration
- Be scheduled to undergo elective cardiac surgery requiring CPB and including: coronary artery bypass graft (CABG), aortic, mitral, or tricuspid valve replacement or repair, replacement of more than one cardiac valve, or CABG with combined cardiac valve replacement or repair.
Who cannot join
- Over the age of 64 years
- Patients who receive allogeneic transfusion 60 days prior to surgery
- Hgb > 15g/dl
- Patients who are pregnant or currently lactating
- Women of childbearing potential (e.g. those not surgically sterilized or not post-menopausal) must use 2 methods of contraception including at least one barrier method.
- End-stage renal disease requiring renal replacement therapy or dialysis
Show all 30Show fewer
- Hepatic dysfunction (defined as total bilirubin value > 1.5 mg/dl)
- Off-pump (no CPB) cardiac surgery
- Emergency surgical procedure
- Inability to receive blood products
- Endocarditis as defined my Modified Duke Criteria
- Any congenital coagulation disorder
- Chronic anemia (defined as preoperative Hgb concentration < 10 g/dl)
- Low platelet count (defined as preoperative platelet count less than 150 x 103/μl)
- Not a surgical candidate due to high risk of morbidity or mortality
- Surgery for aneurysm repair, dissection, or other thoracic aortic procedure
- Congenital heart surgery
- Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery, as defined by systolic blood pressure < 80 mmHg and heart rate > 120 beats per minute
- Known malignancy within the past 5 years
- Life expectancy < 12 months
- Current active infection requiring antibiotic treatment
- Inability to comply with study protocol
- Contraindication to Epogen
- Hypersensitivity to epoetin or any component of the formulation
- Pure red cell aplasia (due to epoetin or other epoetin protein drugs)
- Contraindication to Ferrous Sulfate
- Hypersensitivity to iron salts or any component of the formulation
- Hemochromatosis
- Hemolytic anemia
- In the opinion of the Principle Investigator (PI) any specific disease process or confounding variables that may inappropriately alter the outcome of the study
Trial locations and contacts
1 site in 1 country.
About this study
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Read the detailed description
The investigator proposes a study investigating the use of restrictive transfusion triggers and administration of single preoperative high dose shot of epoetin alfa (rhEPO) in a young (age < 65 years of age) population undergoing cardiac surgery. The investigator believes that participants can tolerate a lower Hemoglobin (Hgb). Therefore, the control group will benefit from a restrictive transfusion trigger and experimental group will benefit from EPO providing a synergistic stimulus for erythropoiesis. This proposed study has potential to reduce overall transfusion utilization in cardiac surgery and improve standard of care.
- Conditions
- Cardiac Surgery-CABG, Cardiac Valve Replacement
- Being tested
- Epogen, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpogenDrug
Also called EPOETIN, Procrit
1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
Normal SalineDrug
Also called Placebo
1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
| Study group | Role | What they receive |
|---|---|---|
| Epogen | Active comparator | 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Receives: Drug: Epogen |
| Normal Saline | Placebo comparator | 250 ml normal saline infused over 1 hr Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period
Measured: Start of surgery to 96 hours post op
Secondary outcomes (3)
Length of Stay (# of Total Days Hospitalized)
Measured: up to one year from date of surgery
Overall Hospitalization Cost
Measured: up to one year from date of surgery
Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey
Measured: assessed at 1-week, 1-month, and 3-months from date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startMay 2015
- Primary completion15 Jun 2016
- Study completion27 Feb 2017
Why it stopped: Loss of funding
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 Cardiac Surgery-CABGStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith A. Horvath, MD, Principal investigator, Johns Hopkins Community Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802592
- Sponsor's protocol ID
- IRB00050961
- Acronym
- EPORT
- Status last verified
- Feb 2019
- First submitted
- 3 Jun 2016
- Last updated
- 26 Feb 2019
- 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 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
- ClinicalTrials.gov ID
- NCT02802592
- Acronym / sponsor ID
- EPORT / IRB00050961
- Conditions
- Cardiac Surgery-CABG, Cardiac Valve Replacement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 14 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Detailed description
The investigator proposes a study investigating the use of restrictive transfusion triggers and administration of single preoperative high dose shot of epoetin alfa (rhEPO) in a young (age < 65 years of age) population undergoing cardiac surgery. The investigator believes that participants can tolerate a lower Hemoglobin (Hgb). Therefore, the control group will benefit from a restrictive transfusion trigger and experimental group will benefit from EPO providing a synergistic stimulus for erythropoiesis. This proposed study has potential to reduce overall transfusion utilization in cardiac surgery and improve standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epogen | Active comparator | Drug: Epogen1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr |
| Normal Saline | Placebo comparator | Drug: Normal Saline250 ml normal saline infused over 1 hr |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be male or female and 18 years of age or older, but less than 65 years of age
- Be willing to performed written informed consent prior to study initiation
- Be willing and able to comply with the protocol for study duration
- Be scheduled to undergo elective cardiac surgery requiring CPB and including: coronary artery bypass graft (CABG), aortic, mitral, or tricuspid valve replacement or repair, replacement of more than one cardiac valve, or CABG with combined cardiac valve replacement or repair.
Key exclusion criteria (30 listed)
- Over the age of 64 years
- Patients who receive allogeneic transfusion 60 days prior to surgery
- Hgb > 15g/dl
- Patients who are pregnant or currently lactating
- Women of childbearing potential (e.g. those not surgically sterilized or not post-menopausal) must use 2 methods of contraception including at least one barrier method.
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 |
|---|---|---|
| EpogenAlso: EPOETIN, Procrit1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm | Drug | Epogen |
| Normal SalineAlso: Placebo1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm | Drug | Normal Saline |
Primary outcome
Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period
Time frame: Start of surgery to 96 hours post op
3 secondary outcomes
Length of Stay (# of Total Days Hospitalized)
Time frame: up to one year from date of surgery
Overall Hospitalization Cost
Time frame: up to one year from date of surgery
Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey
Time frame: assessed at 1-week, 1-month, and 3-months from date of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Keith A. Horvath, MD principal investigator
Johns Hopkins Community Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epogen and Normal Saline in people with Cardiac Surgery-CABG and Cardiac Valve Replacement, run by Johns Hopkins 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 30 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 26 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2017). 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 Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period (time frame: Start of surgery to 96 hours post op). 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 26 Feb 2019.