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Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
NCT03913481 · View on ClinicalTrials.gov ↗
Study Summary
Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery. Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.
Conditions Studied
Interventions
- PROCEDURE Acute normovolemic hemodilution
- PROCEDURE Standard care
Study Locations (20)
Other
- Dante Pazzanese Institute od Cardiology — São Paulo
- Instituto do Coração - Hospital das Clínicas, Faculdade de Medicina - Universidade de São Paulo — São Paulo
- Xijing Hospital — Xi'an
- Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" — Catania
- Città di Lecce Hospital - GVM Care & Research — Lecce
- IRCCS Policlinico San Donato — Milan
- IRCCS Cardiologico Monzino — Milan
- Ospedale San Raffaele di Milano, Italy — Milan
- Azienda Ospedaliera Padova — Padua
- AOU Pisana — Pisa
- Ospedale San Carlo — Potenza
- Policlinico Tor Vergata — Rome
- Azienda Ospedaliero-Universitaria Sant'Andrea — Rome
- Istituto Clinico Humanitas — Rozzano
- San Giovanni di Dio e Ruggi d'Aragona — Salerno
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino — Torino
Oklahoma
- OUHSC - University of Oklahoma — Oklahoma City
Virginia
- University of Virginia — Charlottesville
Bahrain
- Mohammed Bin Khalifa Specialist Cardiac Center — Awali
Ravenna
- Maria Cecilia Hospital — Cotignola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2025-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03913481
The ClinicalTrials.gov registry entry for NCT03913481 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Università Vita-Salute San Raffaele, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with C.Surgical Procedure; Cardiac appearing as the primary indexed condition, and to 2 interventions — of which Acute normovolemic hemodilution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03913481 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Oklahoma, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03913481 about?
NCT03913481 is a clinical study titled "Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.". Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery. Acute normovolemic hemo-dilution (ANH) is a well-known strategy ...
What is the current status of trial NCT03913481?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 2,000 participants. The study started on 2019-04-15. Estimated completion is 2025-12.
What conditions does trial NCT03913481 study?
This clinical trial studies the following conditions: C.Surgical Procedure; Cardiac. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03913481?
The interventions under investigation include: Acute normovolemic hemodilution (PROCEDURE), Standard care (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03913481?
This trial is sponsored by Università Vita-Salute San Raffaele, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03913481 being conducted?
This trial has 20 study locations across Oklahoma, Virginia, Bahrain, Ravenna. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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