Cardiac SurgeryNCT00939978
Effect of Preoperative Recombinant Human Erythropoietin on Transfusion Risk in Valvular Heart Surgery
A study testing rhEPO in people with Cardiac Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- rhEPO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Jul 2010
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The 90 patients who are planned to have the heart surgery during this study period.(minimum age 20)
Who cannot join
- Uncontrolled hypertension(diastolic blood pressure(DBP)>100 mmHg), Hct > 45%, Plt. count)>450,000
- There are no history of seizure, thrombus, cancer, acute hepatitis, alcoholism, peripheral blood vessel disease, pure red blood cell dysfunction, liver function failure, chronic multiple arthritis.
- No pregnancy, acute hyper parathyroidism.
Trial locations and contacts
1 site in 1 country.
About this study
The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery.
- Conditions
- Cardiac Surgery
- Being tested
- rhEPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhEPODrug
recombinant human erythropoietin(rhEPO)
| Study group | Role | What they receive |
|---|---|---|
| Venoferrum | Active comparator | Not described Receives: Drug: rhEPO |
| saline | Placebo comparator | Not described Receives: Drug: rhEPO |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939978
- Sponsor's protocol ID
- 4-2008-0427
- Status last verified
- Oct 2010
- First submitted
- 14 Jul 2009
- Last updated
- 7 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Recombinant Human Erythropoietin on Transfusion Risk in Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT00939978
- Acronym / sponsor ID
- 4-2008-0427
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Jul 2009 (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.
The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venoferrum | Active comparator | Drug: rhEPO |
| saline | Placebo comparator | Drug: rhEPO |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The 90 patients who are planned to have the heart surgery during this study period.(minimum age 20)
Key exclusion criteria (3 listed)
- Uncontrolled hypertension(diastolic blood pressure(DBP)>100 mmHg), Hct > 45%, Plt. count)>450,000
- There are no history of seizure, thrombus, cancer, acute hepatitis, alcoholism, peripheral blood vessel disease, pure red blood cell dysfunction, liver function failure, chronic multiple arthritis.
- No pregnancy, acute hyper parathyroidism.
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 |
|---|---|---|
| rhEPOrecombinant human erythropoietin(rhEPO) | Drug | Venoferrum, saline |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhEPO in people with Cardiac Surgery, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 3 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 7 Oct 2010. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 7 Oct 2010.