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NCT Number: NCT03366753

Impact of Acute Normovolemic Hemodilution on Blood Viscosity

Acute normovolemic hemodilution (ANH) has long been employed for reducing allogenic blood transfusion for cardiac surgery, and hydroxyethyl starch has been used as an intravenous replacement fluid during ANH procedure. However, possible impact of ANH employing HES on blood viscosity and oxygen delivery have not been well investigated in patients undergoing off-pump coronary artery bypass (OPCAB) surgery .

Anesthesia is induced and maintained by using propofol-remifentanil-rocuronium in OPCAB surgery (n=21). ANH is performed by using 5 ml/kg of blood salvage and administering 5 ml/kg of balanced HES 130/0.42 (Tetraspan™) for 15 min during vascular graft harvesting. For the present study, three arterial blood samples (3 ml each) are taken before (Sample 1) and after ANH (sample 2 and 3) and they are stored in 3 tubes. Sample 3 (in tube) undergoes further 30% in-vitro dilution by adding 1-1.5 ml HES. By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at low shear rate (5/sec) of the three samples are determined. By using a formula with blood viscosity and hematocrit, tissue O2 delivery index (TODI, = hematocrit/viscosity at 5/sec) is calculated.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing off-pump coronary artery bypass graft surgery

Exclusion criteria

  • Preoperative anemia
  • LV ejection fraction < 50%

Treatment and study plan

Acute Normovolemic Hemodilution

Procedure

acute normovolemic hemodilution (ANH) is performed by using 5 ml/kg of blood salvage and intravenously administering 5 ml/kg of balanced hydroxyethystarch 130/0.42 (Tetraspan™) for 15 min

In-vitro hemodilution

Procedure

Blood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42

Primary outcomes

  1. blood viscosity at shear rate 5/sec

    Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

    By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 5/sec of the three samples are determined

  2. hematocrit/blood viscosity at 5/sec

    Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

    oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)

Secondary outcomes

  1. blood viscosity at shear rate 300/sec

    Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

    By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 300/sec of the three samples are determined

  2. Hematocrit/viscosity at shear rate 300/sec

    Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

    oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)

  3. Coagulation profiles in ROTEM

    Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

    clot formation time in extem, MCF in extemA5 in fibtem,

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2017
Registry last updated
Dec 29, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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