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Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Study acronym: ANH
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion date: Dec 2025 to Dec 2026
    • Site details revised at 1 of 32 sites
    v17
  2. Site details revised at 27 of 32 sitesv16
  3. Study sites: 12 to 32
    • Primary completion date changed from estimate of Jan 2025 to Jan 19, 2025
    • Study completion date: Jan 2025 to Dec 2025
    • Publications: 2 to 3
    v15
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Feb 2025 to Jan 2025
    • Study completion date: Mar 2025 to Jan 2025
    • Site details revised at 12 of 12 sites
    v14
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Jul 2024 to Feb 2025
    • Study completion date: Sep 2024 to Mar 2025
    v12
  2. Study sites: 9 to 12v11
  3. Primary completion date: Jul 2023 to Jul 2024
    • Study sites: 4 to 9
    • Study completion date: Sep 2023 to Sep 2024
    v10
  4. Re-verified, no change to tracked fieldsv9
  5. Study sites: 1 to 4v8
  6. 4 versions Re-verified since Jul 4, 2019, no change to tracked fieldsv4-v7
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2019 to Apr 15, 2019
    • Site details revised
    v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03913481
Lead Sponsor Università Vita-Salute San Raffaele
Conditions
(from sponsor)		 C.Surgical Procedure; Cardiac
Related terms Burns, Hemorrhage, Sepsis, Wounds and Injuries
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov