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NCT Number: NCT03913481

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 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.

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Key information

Conditions

C.Surgical Procedure; Cardiac Burns Hemorrhage Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammed Bin Khalifa Specialist Cardiac Center, Awali, Bahrain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Acute Normovolemic Hemodilution

Procedure

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

Procedure

Best available treatment without ANH

Primary outcomes

  1. RBCs transfusion

    Time frame: hospital discharge, an average of 10 days

    The number of patients receiving RBCs transfusion after elective cardiac surgery.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.

Acronym: ANH

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Apr 12, 2019
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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