TACO Crossover TRIAL

NCT03135457 | Completed

• 1 other identifier: NL59191.018.16
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion-associated Circulatory Overload; Blood Transfusion Reaction

Outcome Measures

Primary Outcomes (1)

• Hydrostatic pressure overload

  Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure

  1 hour

Secondary Outcomes (17)

• Capillary leakage

  1 hour

• Cardiac output

  1 hour

• Mean arterial pressure

  1 hour

• Pulse pressure variation

  1 hour

• Stroke volume variation

  1 hour

Study Arms (2)

Group A

OTHER

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; Procedure: Saline transfusion

Group B

OTHER

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; Procedure: Saline transfusion

Interventions

Autologous RBC transfusion PROCEDURE

Autologous RBC transfusion 300ml 10 ml/min

Group A; Group B

Saline transfusion PROCEDURE

Saline transfusion 300ml 10ml/min

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with no indication for autologous RBC transfusion
• Patients with pulmonary hypertension, congenital heart disease, mitral or tricuspid valve disease.
• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academisch Medisch Centrum - Universiteit van Amsterdam

Amsterdam, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 27083327 BACKGROUND

• Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

  PMID: 38780066 DERIVED

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Alexander Vlaar, MD PhD MBA

  Academisch Medisch Centrum - Universiteit van Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking of investigator is not possible due to nature of intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD MBA

Model Details: Open-label, prospective cross-over randomized controlled trial.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: August 16, 2017
• Primary Completion: March 13, 2020
• Study Completion: April 1, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)