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Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients. (ANH)

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ClinicalTrials.gov Identifier: NCT03913481
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

Brief 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.


Condition or disease Intervention/treatment Phase
C.Surgical Procedure; Cardiac Procedure: Acute normovolemic hemodilution Procedure: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: ANH
Best available treatments plus ANH, performed withdrawing a volume of blood before the CPB. The volume will be personalized for every patient, but it'll be at least 650ml.
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.

Standard care
No ANH
Procedure: Standard care
Best available treatment without ANH




Primary Outcome Measures :
  1. RBCs transfusion [ Time Frame: hospital discharge, an average of 10 days ]
    The number of patients receiving RBCs transfusion after elective cardiac surgery.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    30-day mortality

  2. Bleeding complications [ Time Frame: hospital discharge, an average of 10 days ]
    • Amount of blood components (RBC, fresh frozen plasma-FFP, platelet -PLT) transfused (units/ml)
    • Estimated total blood volume lost (ml) at 12 hours after surgery
    • Surgical revision for bleeding

  3. Ischemic complications [ Time Frame: hospital discharge,an average of 10 days ]
    • Myocardial infarction
    • Stroke
    • Thromboembolic events

  4. AKI [ Time Frame: hospital discharge, an average of 10 days ]
    Developing of acute kidney injury



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Any cardiac surgical intervention on CPB
  • Elective surgery

Exclusion Criteria:

  • Medical decision (e.g.: planned pre-CPB ANH considered undeniable for ethical reasons or not applicable for safety issues)
  • Unstable Coronary Artery Disease: Recent (< 6 weeks) myocardial infarction, unstable angina, severe (> 70%) left main coronary artery stenosis
  • Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or IABP, preoperative severe acute renal failure (anuria or oliguria <10ml/hr.)
  • Emergency surgery
  • Pregnancy
  • Unfeasibility to withdraw ≥ 650 ml without inducing hemodynamic instability
  • Unfeasibility to withdraw ≥ 650 ml without inducing pre-CPB anemia (Htc <30%)
  • Unfeasibility to withdraw ≥ 650 ml without inducing low Htc during CPB (Htc <24%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913481


Contacts
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Contact: Giovanni Landoni, Prof +39022643 ext 6151 landoni.giovanni@hsr.it

Locations
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Italy
Ospedale San Raffaele di Milano, Italy Recruiting
Milano, Milano, Italy, Italy, 20132
Contact: Giovanni Landoni, Prof         
Sub-Investigator: Fabrizio Monaco, MD         
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
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Study Chair: Alberto Zangrillo, Prof Vita-Salute University of Milano

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Responsible Party: Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT03913481    
Other Study ID Numbers: ANH/35/OSR
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giovanni Landoni, Università Vita-Salute San Raffaele:
tissue
organ and systemic injury responses to surgery
trauma
burn
sepsis
hemorrhage
ischemia- reperfusion
resuscitation
including integrating pathways and signals
cardiac surgery
transfusion