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NCT02189889 · ClinicalTrials.gov registry record · Phase 1
Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02189889 is a Phase 1 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 5 participants.
The verdict
NCT02189889, a Phase 1 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major health problem for patients having heart surgery. Hemoglobin is the part of our blood that carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery, called preoperative anemia, is a risk factor for an increased chance of morbidity (illness) and/or mortality (death) after heart surgery. It is also an important indicator of blood transfusion necessity. Recent clinical research investigations done to study preoperative anemia suggest a blood transfusion can damage the immune system (the system that protects us from disease) which can lead to infection, organ dysfunction (especially of the heart, kidney, brain), prolonged hospital stays, as well as increased supplies, resources and cost in surgical patients. Comprehensive anemia management can reduce or eliminate the need for blood transfusions and provide better outcomes after surgery. Therefore, controlling anemia before surgery is extremely important, and could be a lifesaving measure. This pilot, feasibility study is being done for several reasons. First of all, it will test the the safety and effectiveness of using a short-course of two medications, erythropoietin (EPO) and Feraheme (iron given intravenously \[IV\]), to increase hemoglobin levels in order to improve preoperative anemia, reduce transfusions and lower postoperative complications in anemic patients undergoing heart surgery. Secondly, findings will be used to design a large randomized controlled trial (RCT). The RCT will establish a protocol to actively manage anemia before surgery, thus reducing transfusions during surgery and improving recovery afterwards. It will also help identify valuable information regarding what needs to be done for timely completion of the planned RCT. EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia in patients with certain conditions in order to reduce bloo
Interventions
- DRUG Feraheme
- DRUG EPO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-04-09 |
| Est. Completion | 2019-07-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02189889
The ClinicalTrials.gov registry entry for NCT02189889 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Feraheme is the first listed.
NCT02189889 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02189889 about?
NCT02189889 is a clinical study titled "Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery". Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major health problem for patients having heart surgery. Hemoglobin is the part of our blood that carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery, called preoperative anemi...
What is the current status of trial NCT02189889?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2013-04-09. Estimated completion is 2019-07-26.
What interventions are being tested in trial NCT02189889?
The interventions under investigation include: Feraheme (DRUG), EPO (DRUG).
Who is sponsoring clinical trial NCT02189889?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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