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NCT05049590 · ClinicalTrials.gov registry record · Phase 3
Acute Normovolemic Hemodilution in Complex Cardiac Surgery
A Phase 3 study of Acute Kidney Injury and Congenital Heart Disease, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT05049590 is a Phase 3 study of Acute Kidney Injury and Congenital Heart Disease that has completed, run by University of California, Los Angeles. The registered enrollment target is 63 participants, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05049590, a Phase 3 study of Acute Kidney Injury and Congenital Heart Disease, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
Postoperative bleeding in cardiac surgery is a frequent complication, and cardiac surgery utilizes 15-20% of the national blood supply. Packed red blood cells (pRBCs) are associated with worse short and long term outcomes. For each unit transfused, there is an additive risk of mortality (death) and cardiac adverse events. Despite current guidelines and numerous approaches to bleeding reduction, \>50% of the patients undergoing cardiac surgery receive transfusions. Acute normovolemic hemodilution (ANH), a blood conservation technique that removes whole blood from a patient immediately prior to surgery, could be a valuable method to reduce transfusion in complex cardiac surgery. At the University of California, Los Angeles (UCLA), ANH is routinely utilized in patients who refuse allogenic blood transfusions such as Jehovah's Witnesses. ANH has been shown to be safe with minimal risk to patients. ANH has been studied in simple cardiac surgery, such as coronary artery bypass grafting, however it has not been studied in complex cardiac surgery, such as aortic surgery and adult congenital heart disease. ANH has been demonstrated to reduce pRBC transfusion in lower risk cardiac surgery without any significant complications. Complex heart surgery utilizes more blood products. This study could identify the benefits of ANH in a higher risk surgical group.
Conditions Studied
Interventions
- BIOLOGICAL Acute normovolemic hemodilution (ANH)
Study Locations (1)
California
- Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2023-06-22 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05049590
The ClinicalTrials.gov registry entry for NCT05049590 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (97% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention - of which Acute normovolemic hemodilution (ANH) is the first listed.
NCT05049590 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05049590 about?
NCT05049590 is a clinical study titled "Acute Normovolemic Hemodilution in Complex Cardiac Surgery". Postoperative bleeding in cardiac surgery is a frequent complication, and cardiac surgery utilizes 15-20% of the national blood supply. Packed red blood cells (pRBCs) are associated with worse short and long term outcomes. For each unit transfused, there is an additive risk of mortality (death) and ...
What is the current status of trial NCT05049590?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2022-02-28. Estimated completion is 2023-06-22.
What conditions does trial NCT05049590 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Congenital Heart Disease, Cardiac Surgery, Aortic Surgery.
What interventions are being tested in trial NCT05049590?
The interventions under investigation include: Acute normovolemic hemodilution (ANH) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05049590?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05049590 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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