TACO Crossover TRIAL

Not Applicable

Completed

• Conditions: Transfusion-associated Circulatory Overload; Blood Transfusion Reaction
• Interventions: Procedure: Autologous RBC transfusion; Procedure: Saline transfusion

• Registration Number: NCT03135457
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Study Start: 2017-08-16
• Primary Completion: 2020-03-13
• Study Completion: 2020-04-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-02
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Autologous RBC transfusion	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
Group A	Saline transfusion	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
Group B	Autologous RBC transfusion	Patients will receive infusion of 300mL autologous RBC with a subsequent saline transfusion of 300 mL at a rate of 10mL/min
Group B	Saline transfusion	Patients will receive infusion of 300mL autologous RBC with a subsequent saline transfusion of 300 mL at a rate of 10mL/min

Primary Outcome Measures

Name	Time	Method
Hydrostatic pressure overload	1 hour	Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure

Secondary Outcome Measures

Name	Time	Method
Pulse pressure variation	1 hour	Volume overload measured by pulse pressure variation
Microcirculation	1 hour	Blood vessel diameters in the sublingual microcirculation measured by Cytocam
Cardiac output	1 hour	Volume overload measured by cardiac output
Systemic vascular resistance	1 hour	Volume overload measured by systemic vascular resistance
Capillary leakage	1 hour	Capillary leakage defined as delta extra vascular lung water index
Mean arterial pressure	1 hour	Volume overload measured by mean arterial pressure
Stroke volume variation	1 hour	Volume overload measured by stroke volume variation
Colloid osmotic pressure	1 hour	Colloid osmotic pressure measured by membrane colloid osmometer
Estimated circulating volume	1 hour	Estimated circulating plasma volume measured by indocyanine green
Extra vascular lung water index	1 hour	Volume overload measured by extra vascular lung water index
TACO	6 hours	Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion
Fluid responsiveness	1 hour	Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output \> 10%)

Trial Locations

Locations (1)

Academisch Medisch Centrum - Universiteit van Amsterdam; 🇳🇱 Amsterdam, Netherlands