TACO Crossover TRIAL

Transfusion-associated Circulatory Overload Clinical Trial

Official title:

A Cross-over Randomized Controlled Trial; Pulmonary Edema Detection After Fluid Loading With Blood Versus Saline in Patients After CABG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135457
• Other study ID #: NL59191.018.16
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 1, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion Reaction
• Transfusion Reaction
• Transfusion-associated Circulatory Overload

Intervention

Procedure:
• Autologous RBC transfusion
Autologous RBC transfusion 300ml 10 ml/min
• Saline transfusion
Saline transfusion 300ml 10ml/min

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum - Universiteit van Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydrostatic pressure overload	Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure	1 hour
Secondary	Capillary leakage	Capillary leakage defined as delta extra vascular lung water index	1 hour
Secondary	Cardiac output	Volume overload measured by cardiac output	1 hour
Secondary	Mean arterial pressure	Volume overload measured by mean arterial pressure	1 hour
Secondary	Pulse pressure variation	Volume overload measured by pulse pressure variation	1 hour
Secondary	Stroke volume variation	Volume overload measured by stroke volume variation	1 hour
Secondary	Extra vascular lung water index	Volume overload measured by extra vascular lung water index	1 hour
Secondary	Systemic vascular resistance	Volume overload measured by systemic vascular resistance	1 hour
Secondary	Colloid osmotic pressure	Colloid osmotic pressure measured by membrane colloid osmometer	1 hour
Secondary	Estimated circulating volume	Estimated circulating blood volume measured by indocyanine green	1 hour
Secondary	Estimated circulating volume	Estimated circulating plasma volume measured by indocyanine green	1 hour
Secondary	Microcirculation	Total vessel density in the sublingual microcirculation measured by Cytocam	1 hour
Secondary	Microcirculation	Perfused vessel density in the sublingual microcirculation measured by Cytocam	1 hour
Secondary	Microcirculation	Proportion of perfused vessels in the sublingual microcirculation measured by Cytocam	1 hour
Secondary	Microcirculation	Microvascular flow index in the sublingual microcirculation measured by Cytocam	1 hour
Secondary	Microcirculation	Blood vessel diameters in the sublingual microcirculation measured by Cytocam	1 hour
Secondary	Fluid responsiveness	Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output > 10%)	1 hour
Secondary	TACO	Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion	6 hours