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Transfusion-associated Circulatory OverloadNCT03135457

TACO Crossover TRIAL

A study testing Autologous RBC transfusion and Saline transfusion in people with Transfusion-associated Circulatory Overload and Blood Transfusion Reaction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Autologous RBC transfusion and Saline transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNetherlands
Study dates
16 Aug 2017to 1 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Academisch Medisch Centrum - Universiteit van Amsterdam

    Amsterdam

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Autologous RBC transfusion, Saline transfusion
Medical subject headings
Transfusion Reaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous RBC transfusionProcedure or surgery

    Autologous RBC transfusion 300ml 10 ml/min

  • Saline transfusionProcedure or surgery

    Saline transfusion 300ml 10ml/min

Study groups in NCT03135457
Study groupRoleWhat they receive
Group AOtherPatients will receive infusion of 300mL saline with a subsequent autologous Red Blood Cells (RBC) transfusion of 300 mL at a rate of 10mL/min
Receives: Procedure: Autologous RBC transfusion; Procedure: Saline transfusion
Group BOtherPatients will receive infusion of 300mL autologous RBC with a subsequent saline transfusion of 300 mL at a rate of 10mL/min
Receives: Procedure: Autologous RBC transfusion; Procedure: Saline transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hydrostatic pressure overload

    Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure

    Measured: 1 hour

Secondary outcomes (17)

  1. Capillary leakage

    Capillary leakage defined as delta extra vascular lung water index

    Measured: 1 hour

  2. Cardiac output

    Volume overload measured by cardiac output

    Measured: 1 hour

  3. Mean arterial pressure

    Volume overload measured by mean arterial pressure

    Measured: 1 hour

  4. Pulse pressure variation

    Volume overload measured by pulse pressure variation

    Measured: 1 hour

  5. Stroke volume variation

    Volume overload measured by stroke volume variation

    Measured: 1 hour

  6. Extra vascular lung water index

    Volume overload measured by extra vascular lung water index

    Measured: 1 hour

  7. Systemic vascular resistance

    Volume overload measured by systemic vascular resistance

    Measured: 1 hour

  8. Colloid osmotic pressure

    Colloid osmotic pressure measured by membrane colloid osmometer

    Measured: 1 hour

  9. Estimated circulating volume

    Estimated circulating blood volume measured by indocyanine green

    Measured: 1 hour

  10. Estimated circulating volume

    Estimated circulating plasma volume measured by indocyanine green

    Measured: 1 hour

  11. Microcirculation

    Total vessel density in the sublingual microcirculation measured by Cytocam

    Measured: 1 hour

  12. Microcirculation

    Perfused vessel density in the sublingual microcirculation measured by Cytocam

    Measured: 1 hour

  13. Microcirculation

    Proportion of perfused vessels in the sublingual microcirculation measured by Cytocam

    Measured: 1 hour

  14. Microcirculation

    Microvascular flow index in the sublingual microcirculation measured by Cytocam

    Measured: 1 hour

  15. Microcirculation

    Blood vessel diameters in the sublingual microcirculation measured by Cytocam

    Measured: 1 hour

  16. Fluid responsiveness

    Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output > 10%)

    Measured: 1 hour

  17. TACO

    Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2017
  2. Study start16 Aug 2017
  3. Primary completion13 Mar 2020
  4. Study completion1 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Open-label, prospective cross-over randomized controlled trial.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03135457
Sponsor's protocol ID
NL59191.018.16
Status last verified
Aug 2020
First submitted
26 Apr 2017
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27083327

  • 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.

    PubMed 38780066

Questions about this trial

What is this clinical trial studying?

A study testing Autologous RBC transfusion and Saline transfusion in people with Transfusion-associated Circulatory Overload and Blood Transfusion Reaction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hydrostatic pressure overload (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03135457, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.

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