Trials / Active Not Recruiting
Active Not RecruitingNCT03913481
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,000 (estimated)
- Sponsor
- Università Vita-Salute San Raffaele · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Acute normovolemic hemodilution | In the ANH arm, after induction of general anesthesia, a total blood volume of at least 650 ml of blood will be drawn from a central line. The amount of volume drawn can be replaced with Ringer lactate or a similar crystalloid fluid up to a 3:1 ratio. |
| PROCEDURE | Standard care | Best available treatment without ANH |
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2025-01-19
- Completion
- 2025-12-01
- First posted
- 2019-04-12
- Last updated
- 2025-08-07
Locations
32 sites across 11 countries: United States, Bahrain, Brazil, China, Italy, Russia, Saudi Arabia, Serbia, Singapore, Thailand, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT03913481. Inclusion in this directory is not an endorsement.