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Trial record 1 of 1 for:    NCT03135457
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TACO Crossover TRIAL

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ClinicalTrials.gov Identifier: NCT03135457
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
A.P.J. Vlaar, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
This is an open-label, prospective crossover randomized controlled trial to investigate wether TACO is solely hydrostatic pressure overload or arises from a combination of hydrostatic pressure overload and capillary leakage, by investigating the difference in change in static pressure parameters (PCWP), dynamic volume parameters (PICCO) as indirect measurements of volume status and capillary leakage after autologous transfusion or saline infusion. The investigators will estimate effective circulating volume following autologous transfusion or saline infusion. Furthermore, the investigators will investigate the effect of fluid loading on the microcirculation.

Condition or disease Intervention/treatment Phase
Transfusion-associated Circulatory Overload Blood Transfusion Reaction Procedure: Autologous RBC transfusion Procedure: Saline transfusion Not Applicable

Detailed Description:
Coronary arterial bypass grafting surgery patients with reduced left ventricular function will be allocated to either infusion of 300mL saline with a subsequent autologous RBC (cell saver) transfusion of 300 mL at a rate of 10mL/min, or the same in the reversed order. Prior to start of the intervention, 15 minutes following start of infusion and a the end of infusion, the investigators will measure right-ventricular pressure and wedge pressure (PCWP), as well as extravascular lung water index (EVLWI) and CO estimation through PICCO® and Pulmonary Artery Catheter. The investigators will identify fluid responsiveness by performing a passive leg raise test (PLR). The investigators aim to measure total vessel density (TVD), perfused vessel density (PVD), proportion of perfused vessels (PPV), microvascular flow index (MFI), and blood vessel diameters (Øbv) from the oral microcirculation by CytoCam microscope system. The investigators will estimate the effective circulating blood and plasma volume through dilutional infusion of indocyanine green prior to initial infusion, between and at the end of subsequent infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open-label, prospective cross-over randomized controlled trial.
Masking: Double (Participant, Care Provider)
Masking Description: Masking of investigator is not possible due to nature of intervention.
Primary Purpose: Basic Science
Official Title: A Cross-over Randomized Controlled Trial; Pulmonary Edema Detection After Fluid Loading With Blood Versus Saline in Patients After CABG
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020


Arm Intervention/treatment
Group A
Patients will receive infusion of 300mL saline with a subsequent autologous Red Blood Cells (RBC) transfusion of 300 mL at a rate of 10mL/min
Procedure: Autologous RBC transfusion
Autologous RBC transfusion 300ml 10 ml/min

Procedure: Saline transfusion
Saline transfusion 300ml 10ml/min

Group B
Patients will receive infusion of 300mL autologous RBC with a subsequent saline transfusion of 300 mL at a rate of 10mL/min
Procedure: Autologous RBC transfusion
Autologous RBC transfusion 300ml 10 ml/min

Procedure: Saline transfusion
Saline transfusion 300ml 10ml/min




Primary Outcome Measures :
  1. Hydrostatic pressure overload [ Time Frame: 1 hour ]
    Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure


Secondary Outcome Measures :
  1. Capillary leakage [ Time Frame: 1 hour ]
    Capillary leakage defined as delta extra vascular lung water index

  2. Cardiac output [ Time Frame: 1 hour ]
    Volume overload measured by cardiac output

  3. Mean arterial pressure [ Time Frame: 1 hour ]
    Volume overload measured by mean arterial pressure

  4. Pulse pressure variation [ Time Frame: 1 hour ]
    Volume overload measured by pulse pressure variation

  5. Stroke volume variation [ Time Frame: 1 hour ]
    Volume overload measured by stroke volume variation

  6. Extra vascular lung water index [ Time Frame: 1 hour ]
    Volume overload measured by extra vascular lung water index

  7. Systemic vascular resistance [ Time Frame: 1 hour ]
    Volume overload measured by systemic vascular resistance

  8. Colloid osmotic pressure [ Time Frame: 1 hour ]
    Colloid osmotic pressure measured by membrane colloid osmometer

  9. Estimated circulating volume [ Time Frame: 1 hour ]
    Estimated circulating blood volume measured by indocyanine green

  10. Estimated circulating volume [ Time Frame: 1 hour ]
    Estimated circulating plasma volume measured by indocyanine green

  11. Microcirculation [ Time Frame: 1 hour ]
    Total vessel density in the sublingual microcirculation measured by Cytocam

  12. Microcirculation [ Time Frame: 1 hour ]
    Perfused vessel density in the sublingual microcirculation measured by Cytocam

  13. Microcirculation [ Time Frame: 1 hour ]
    Proportion of perfused vessels in the sublingual microcirculation measured by Cytocam

  14. Microcirculation [ Time Frame: 1 hour ]
    Microvascular flow index in the sublingual microcirculation measured by Cytocam

  15. Microcirculation [ Time Frame: 1 hour ]
    Blood vessel diameters in the sublingual microcirculation measured by Cytocam

  16. Fluid responsiveness [ Time Frame: 1 hour ]
    Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output > 10%)

  17. TACO [ Time Frame: 6 hours ]
    Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion



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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:

  1. Age >18 years
  2. Elective (non-redo) coronary arterial bypass grafting surgery
  3. Reduced left ventricular ejection fraction (<55%)
  4. Transfusion of autologous blood (cell saver blood, 300ml, HCT60%, 30min)
  5. Informed consent

Exclusion Criteria:

  1. Patients with no indication for autologous RBC transfusion
  2. Patients with pulmonary hypertension, congenital heart disease, mitral or tricuspid valve disease.
  3. Contraindications for PAC placement; coagulopathy, bundle branch block, defibrillator or pacemaker (risk of displacement). External pacemaker placed during surgery is no exclusion criterium.
  4. Patients for acute, non-elective surgery
  5. Chronic kidney disease stage 4 or higher (eGFR < 30)
  6. Massive transfusion
  7. Previous randomization in the current trial
  8. Postoperative ongoing bleeding
  9. Bypass duration > 2 hours
  10. Infusion of high dose corticosteroids
  11. Hemodynamic instability with a mean arterial pressure (MAP) < 60 mmHg, central venous pressure > 20 mmHg or dependence on high dosages of inotropic drugs after admittance to the ICU
  12. Severe arrhythmias
  13. Development of severe pulmonary edema during infusion of autologous blood or saline.
  14. Elevated liver enzymes
  15. Iodine allergy

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): NCT03135457


Contacts
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Contact: Alexander PJ Vlaar, MD PhD MBA 0031-20-5669111 a.p.vlaar@amc.uva.nl

Locations
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Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam Recruiting
Amsterdam, Netherlands
Contact: Alexander PJ Vlaar, MD PhD MBA       a.p.vlaar@amc.uva.nl   
Contact: Bart F Geerts, MD PhD MSc       b.f.geerts@amc.uva.nl   
Sub-Investigator: Joachim J Bosboom, MD         
Principal Investigator: Alexander PJ Vlaar, MD PhD MBA         
Sub-Investigator: Bart F Geerts, MD PhD MSc         
Sub-Investigator: Robert B Klanderman, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Alexander Vlaar, MD PhD MBA Academisch Medisch Centrum - Universiteit van Amsterdam
Publications:
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Responsible Party: A.P.J. Vlaar, MD PhD MBA, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03135457    
Other Study ID Numbers: NL59191.018.16
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Transfusion Reaction
Hematologic Diseases
Immune System Diseases