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NCT03913481 · ClinicalTrials.gov registry record · NA
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
A NA study of C.Surgical Procedure; Cardiac, sponsored by Università Vita-Salute San Raffaele.
- Active
- Registry status
- NA
- Development phase
- 2,000
- Enrollment target
- 20
- Study locations
NCT03913481: Active NA study of C.Surgical Procedure; Cardiac, sponsored by Università Vita-Salute San Raffaele.
NCT03913481 is a NA study of C.Surgical Procedure; Cardiac that is active but no longer recruiting, run by Università Vita-Salute San Raffaele. The registered enrollment target is 2,000 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913481, a NA study of C.Surgical Procedure; Cardiac, is active but no longer recruiting, sponsored by Università Vita-Salute San Raffaele.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 2,000 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The number of patients receiving RBCs transfusion after elective cardiac surgery.
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 |
What the registry record for NCT03913481 still lists
NCT03913481 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher).
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.
NCT03913481 names 20 study sites across 5 states, led by Other, Oklahoma, Virginia.
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.
What interventions are being tested in trial NCT03913481?
The interventions under investigation include: Acute normovolemic hemodilution (PROCEDURE), Standard care (PROCEDURE).
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.
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.
Learn More About Clinical Trials
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Where NCT03913481's enrollment target sits among peer trials
2,000 52nd of 2000 higher than 1,947 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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