Validation of a Red Blood Cell Transfusion Prediction Model in a Low Transfusion Rate Population.

NCT05581238 | Completed DMC

• 1 other identifier: Protocol_TRACK-TCT_v 2.0
• Study Type: observational
• Target: 6,428
• Locations: 1 country
• Sites: 1

Brief Summary

The transfusion risk and clinical knowledge (TRACK) allogeneic blood transfusion prediction model was developed more than ten years ago and demonstrated good discriminative ability in patients with increased risk for allogeneic blood transfusion in an all Italian population. At the time of derivation, dual anti-platelet medication was suggested in the treatment of acute coronary syndrome, but not yet fully implemented. The aim of this study is to externally validate the TRACK blood transfusion prediction model in the cardiac surgery population of Medisch Spectrum Twente Thoraxcentrum Twente. Additionally, the impact of adding the preoperative use of dual anti-platelet medication, as additional predictive factor, to the TRACK blood transfusion prediction model will be investigated.

Conditions

Platelet Aggregation; Blood Transfusion

Keywords

External validation; Blood transfusion; P2Y12 Receptor Inhibitor; Prediction Model

Outcome Measures

Primary Outcomes (2)

• External validation TRACK blood prediction Model (TRACK)

  Does adding P2Y12 inhibitors as extra variable to the TRACK model after validation improve the predictive capacity? This will be done by validation of the TRACK model in the cardiac surgery population of TCT by calculating the discriminative ability. The change in discriminative ability, after correction for optimism, when the pre-operative use of P2Y12 inhibitors is added as extra variable will be assessed and the net improvement in reclassification will be calculated.

  1 year

• Evaluation of the change in predictive capacity when adding P2Y12 as extra variable (TRACK-TCT)

  Does adding P2Y12 inhibitors as extra variable to the TRACK model after validation improve the predictive capacity? This will be done by validation of the TRACK model in the cardiac surgery population of TCT by calculating the discriminative ability. The change in discriminative ability, after correction for optimism, when the pre-operative use of P2Y12 inhibitors is added as extra variable will be assessed and the net improvement in reclassification will be calculated.

  1 year

Secondary Outcomes (3)

• Male vs Female

  1 year

• Post operative complication in patients that received a blood transfusion

  1 year

• Mortality difference in patients that received a blood transfusion

  1 year

Study Arms (2)

TRACK

External validation of TRACK prediction model with 5 variables: age, weight, sex, pre-op HCT, Type of surgery.

TRACK-TCT

New model development with 6 variables. 5 From the TRACK model: age, weight, sex, pre-op HCT, Type of surgery. A sixth variable will be added i.e.: pre-operative P2Y12 drug use

Other: TRACK-TCT

Interventions

TRACK-TCT OTHER

An extra variable will be added to an existing prediction model. It is hypothesized that the predictive ability will improve and that better distinction could be made between patients with an increased risk for receiving blood transfusions.

TRACK-TCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients, 18 years and older, who underwent any cardiac surgery with the use of a heart lung machine, between 1 January 2016 and 31 December 2021 in the Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede.

You may qualify if:

• Patients receiving on-pump cardiac surgery

You may not qualify if:

• Patients who opted out for reuse of their data for scientific purposes

Sponsors & Collaborators

• Medisch Spectrum Twente: lead

Study Sites (1)

Thoraxcentrum Twente

Enschede, Overijssel, 7500KA, Netherlands

Location

Related Publications (7)

• Gorlinger K, Shore-Lesserson L, Dirkmann D, Hanke AA, Rahe-Meyer N, Tanaka KA. Management of hemorrhage in cardiothoracic surgery. J Cardiothorac Vasc Anesth. 2013 Aug;27(4 Suppl):S20-34. doi: 10.1053/j.jvca.2013.05.014.

  PMID: 23910533 BACKGROUND

• Raphael J, Mazer CD, Subramani S, Schroeder A, Abdalla M, Ferreira R, Roman PE, Patel N, Welsby I, Greilich PE, Harvey R, Ranucci M, Heller LB, Boer C, Wilkey A, Hill SE, Nuttall GA, Palvadi RR, Patel PA, Wilkey B, Gaitan B, Hill SS, Kwak J, Klick J, Bollen BA, Shore-Lesserson L, Abernathy J, Schwann N, Lau WT. Society of Cardiovascular Anesthesiologists Clinical Practice Improvement Advisory for Management of Perioperative Bleeding and Hemostasis in Cardiac Surgery Patients. Anesth Analg. 2019 Nov;129(5):1209-1221. doi: 10.1213/ANE.0000000000004355.

  PMID: 31613811 BACKGROUND

• Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.

  PMID: 29029990 BACKGROUND

• Karkouti K, Wijeysundera DN, Yau TM, Beattie WS, Abdelnaem E, McCluskey SA, Ghannam M, Yeo E, Djaiani G, Karski J. The independent association of massive blood loss with mortality in cardiac surgery. Transfusion. 2004 Oct;44(10):1453-62. doi: 10.1111/j.1537-2995.2004.04144.x.

  PMID: 15383018 BACKGROUND

• Ranucci M, Bozzetti G, Ditta A, Cotza M, Carboni G, Ballotta A. Surgical reexploration after cardiac operations: why a worse outcome? Ann Thorac Surg. 2008 Nov;86(5):1557-62. doi: 10.1016/j.athoracsur.2008.07.114.

  PMID: 19049749 BACKGROUND

• Khan B, Islam MU, Ahmad I, Rehman MU. Modifiable Risk Factors associated with Post-Operative Bleeding and transfusion requirements in Cardiac Surgery. Pak J Med Sci. 2022 Mar-Apr;38(4Part-II):855-861. doi: 10.12669/pjms.38.4.5685.

  PMID: 35634631 BACKGROUND

• Haumann R, Plonek T, Niesten E, Maaskant J, Arens J, van der Palen J, Halfwerk F. Validation and optimization of a blood transfusion prediction model for low transfusion rate adult cardiac surgery. Perfusion. 2025 Apr 19:2676591251334903. doi: 10.1177/02676591251334903. Online ahead of print.

  PMID: 40252042 DERIVED

Study Officials

• Frank R Halfwerk, MD PhD

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: January 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: During this year (2024)

Locations

NL (1)