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TACO Crossover TRIAL

Primary Purpose

Transfusion-associated Circulatory Overload, Blood Transfusion Reaction

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Autologous RBC transfusion
Saline transfusion
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Transfusion-associated Circulatory Overload

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academisch Medisch Centrum - Universiteit van Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A

Group B

Arm Description

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

Patients will receive infusion of 300mL autologous RBC with a subsequent saline transfusion of 300 mL at a rate of 10mL/min

Outcomes

Primary Outcome Measures

Hydrostatic pressure overload
Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure

Secondary Outcome Measures

Capillary leakage
Capillary leakage defined as delta extra vascular lung water index
Cardiac output
Volume overload measured by cardiac output
Mean arterial pressure
Volume overload measured by mean arterial pressure
Pulse pressure variation
Volume overload measured by pulse pressure variation
Stroke volume variation
Volume overload measured by stroke volume variation
Extra vascular lung water index
Volume overload measured by extra vascular lung water index
Systemic vascular resistance
Volume overload measured by systemic vascular resistance
Colloid osmotic pressure
Colloid osmotic pressure measured by membrane colloid osmometer
Estimated circulating volume
Estimated circulating blood volume measured by indocyanine green
Estimated circulating volume
Estimated circulating plasma volume measured by indocyanine green
Microcirculation
Total vessel density in the sublingual microcirculation measured by Cytocam
Microcirculation
Perfused vessel density in the sublingual microcirculation measured by Cytocam
Microcirculation
Proportion of perfused vessels in the sublingual microcirculation measured by Cytocam
Microcirculation
Microvascular flow index in the sublingual microcirculation measured by Cytocam
Microcirculation
Blood vessel diameters in the sublingual microcirculation measured by Cytocam
Fluid responsiveness
Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output > 10%)
TACO
Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion

Full Information

First Posted
April 26, 2017
Last Updated
August 2, 2020
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT03135457
Brief Title
TACO Crossover TRIAL
Official Title
A Cross-over Randomized Controlled Trial; Pulmonary Edema Detection After Fluid Loading With Blood Versus Saline in Patients After CABG
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transfusion-associated Circulatory Overload, Blood Transfusion Reaction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Open-label, prospective cross-over randomized controlled trial.
Masking
ParticipantCare Provider
Masking Description
Masking of investigator is not possible due to nature of intervention.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
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
Arm Title
Group B
Arm Type
Other
Arm Description
Patients will receive infusion of 300mL autologous RBC with a subsequent saline transfusion of 300 mL at a rate of 10mL/min
Intervention Type
Procedure
Intervention Name(s)
Autologous RBC transfusion
Intervention Description
Autologous RBC transfusion 300ml 10 ml/min
Intervention Type
Procedure
Intervention Name(s)
Saline transfusion
Intervention Description
Saline transfusion 300ml 10ml/min
Primary Outcome Measure Information:
Title
Hydrostatic pressure overload
Description
Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Capillary leakage
Description
Capillary leakage defined as delta extra vascular lung water index
Time Frame
1 hour
Title
Cardiac output
Description
Volume overload measured by cardiac output
Time Frame
1 hour
Title
Mean arterial pressure
Description
Volume overload measured by mean arterial pressure
Time Frame
1 hour
Title
Pulse pressure variation
Description
Volume overload measured by pulse pressure variation
Time Frame
1 hour
Title
Stroke volume variation
Description
Volume overload measured by stroke volume variation
Time Frame
1 hour
Title
Extra vascular lung water index
Description
Volume overload measured by extra vascular lung water index
Time Frame
1 hour
Title
Systemic vascular resistance
Description
Volume overload measured by systemic vascular resistance
Time Frame
1 hour
Title
Colloid osmotic pressure
Description
Colloid osmotic pressure measured by membrane colloid osmometer
Time Frame
1 hour
Title
Estimated circulating volume
Description
Estimated circulating blood volume measured by indocyanine green
Time Frame
1 hour
Title
Estimated circulating volume
Description
Estimated circulating plasma volume measured by indocyanine green
Time Frame
1 hour
Title
Microcirculation
Description
Total vessel density in the sublingual microcirculation measured by Cytocam
Time Frame
1 hour
Title
Microcirculation
Description
Perfused vessel density in the sublingual microcirculation measured by Cytocam
Time Frame
1 hour
Title
Microcirculation
Description
Proportion of perfused vessels in the sublingual microcirculation measured by Cytocam
Time Frame
1 hour
Title
Microcirculation
Description
Microvascular flow index in the sublingual microcirculation measured by Cytocam
Time Frame
1 hour
Title
Microcirculation
Description
Blood vessel diameters in the sublingual microcirculation measured by Cytocam
Time Frame
1 hour
Title
Fluid responsiveness
Description
Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output > 10%)
Time Frame
1 hour
Title
TACO
Description
Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years Elective (non-redo) coronary arterial bypass grafting surgery Reduced left ventricular ejection fraction (<55%) Transfusion of autologous blood (cell saver blood, 300ml, HCT60%, 30min) Informed consent Exclusion Criteria: Patients with no indication for autologous RBC transfusion Patients with pulmonary hypertension, congenital heart disease, mitral or tricuspid valve disease. Contraindications for PAC placement; coagulopathy, bundle branch block, defibrillator or pacemaker (risk of displacement). External pacemaker placed during surgery is no exclusion criterium. Patients for acute, non-elective surgery Chronic kidney disease stage 4 or higher (eGFR < 30) Massive transfusion Previous randomization in the current trial Postoperative ongoing bleeding Bypass duration > 2 hours Infusion of high dose corticosteroids 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 Severe arrhythmias Development of severe pulmonary edema during infusion of autologous blood or saline. Elevated liver enzymes Iodine allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Vlaar, MD PhD MBA
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academisch Medisch Centrum - Universiteit van Amsterdam
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27083327
Citation
Delaney M, Wendel S, Bercovitz RS, Cid J, Cohn C, Dunbar NM, Apelseth TO, Popovsky M, Stanworth SJ, Tinmouth A, Van De Watering L, Waters JH, Yazer M, Ziman A; Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Transfusion reactions: prevention, diagnosis, and treatment. Lancet. 2016 Dec 3;388(10061):2825-2836. doi: 10.1016/S0140-6736(15)01313-6. Epub 2016 Apr 12.
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TACO Crossover TRIAL

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