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Completed

NCT Number: NCT03717649

Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit (CPB)

Study to measure the ability of a 'fenestrated' venous line cannula to reduce the negative line pressure seen with kinetic-assist active venous drainage (KAVD) in a standard miniaturised cardiopulmonary bypass circuit and thereby increase the flow characteristics of the bypass pump.

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Key information

Conditions

Heart Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

To investigate whether a new venous drainage pipe (cannula) which has three sets of drainage holes (three-stage) compared with the standard two-stage cannula, or a three-stage which also has additional windows (fenestrations), can improve the drainage of blood into the circuit, reducing the negative pressure produced and increase the blood flow delivered to the patient. Patients who consent to participate will be randomly assigned to one of three types of venous cannula:

  • Standard venous cannulation with a two-stage venous cannula
  • The three-stage cannula (91437C, Medtronic)
  • The fenestrated three-stage cannula (MC2X, Medtronic)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients over the age of 18 years of age scheduled to undergo isolated Coronary Artery Bypass Grafting (CABG) or isolated Aortic Valve Replacement (AVR), who are able and willing to consent.
  • Consultant surgeon willing to operate using either Mini-CPB for CABG or AVR surgery.

Exclusion criteria

  • Re-operation and emergency surgery
  • Patients refusing or unable to provide informed consent

Treatment and study plan

Conventional 2-stage venous cannula

Device

venous cannula

Conventional 3-stage venous cannula

Device

venous cannula

Fenestrated 3-stage venous cannula

Device

venous cannula

Primary outcomes

  1. Average blood flow

    Time frame: duration of surgery

    Average blood flow measured in litres per minute per body surface area meter (squared).

Secondary outcomes

  1. Negative pressure readings

    Time frame: duration of surgery

    The duration and depth of negative pressure readings from the venous line during cardiopulmonary bypass (CPB) are made in negative pressure readings in mmHg.

  2. Number of microbubbles

    Time frame: duration of surgery

    Measured as total count (n).

  3. Size of microbubbles

    Time frame: duration of surgery

    Measured as total volume (ml).

  4. Haemolysis

    Time frame: duration of surgery

    Differences in the rate of haemolysis associated with the cannula is measured by the relative increase in plasma alanine aminotransferase (ALT) concentration U/l, as a percentage change from baseline at each of 3 later timepoints.

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study title

Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit - the Influence of a Fenestrated Venous Cannula and Its Effect on Pump Flow

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2018
Registry last updated
Oct 24, 2018

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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