Platelet AggregationTRACK-TCTNCT05581238
Validation of a Red Blood Cell Transfusion Prediction Model in a Low Transfusion Rate Population.
An observational study of Platelet Aggregation and Blood Transfusion, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Aggregation, Blood Transfusion
- What is being tested?
- TRACK-TCT
- How many people
- 6,428 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2022to 1 Jan 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients receiving on-pump cardiac surgery
Who cannot join
- Patients who opted out for reuse of their data for scientific purposes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation of the TRACK Allogeneic Transfusion Model in a Dutch Adult Cardiac Surgery Population, and the Effect on Discriminative Ability When Adding Anti-platelet Therapy
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.
Read the detailed description
Cardiothoracic surgery is associated with increased perioperative blood loss and the need for allogeneic blood and blood product transfusions. This is due to three distinct factors, the invasive nature of the surgical procedures, the need for high dose anti-coagulation during extracorporeal circulation, and lastly the exposure of blood to the internal surface area of the heart-lung machine. Most cardiac patients use anti-platelet therapy before and after surgery, making hemostasis management in this specific patient population even more complex. European guidelines recommend administering anti-platelet therapy using Aspirin in combination with platelet receptor inhibitors such as Clopidogrel, Prasugrel or Ticagrelor, also known as dual anti-platelet therapy in patients with acute coronary syndrome.
Making distinct decisions regarding individual patient hemostasis management remains challenging. Decision making supported by prediction models, such as, EuroSCORE is well established in the cardiac surgery population. A few models pertaining specifically to allogeneic blood transfusion have been created and externally validated. Most of these prediction models perform reasonably well, predicting red blood cell transfusions with seventy-eighty percent accuracy, depending on the model and number of prediction factors used. Some are even excellent for predicting the chance of severe post-operative bleeding. As the transfusion of even one unit of allogeneic blood transfusion impacts mortality, the choice for the best feasible prediction model for routine clinical practice that reflects daily practice, uses a limited number of predictive factors, has a predictive capacity of more than seventy percent, and discriminates between risk groups for allogeneic blood transfusion is desirable.
Transfusion Risk and Clinical Knowledge (TRACK) model validation and optimization The TRACK model was developed more than ten years ago in an Italian adult cardiac surgery population. The decision to validate the TRACK model was based on its simplicity and relatively high predictive capacity, in comparison to other models with higher numbers of complex factors. This model has an allogeneic blood transfusion predictive capacity of seventy-two percent and uses a point system to divide patients into different risk groups, according to the total number of points allocated. During the derivation of this model, dual anti-platelet medication was included, but no significant association was found. In the twelve years since development, the popularity of dual anti-platelet medication used in acute coronary syndrome patients has significantly increased and its association with post-operative bleeding and allogeneic blood transfusion has been suggested.
Recent studies suggest that platelet activity may play a significant role in the prediction of post-operative bleeding, and one research group found that adding platelet activity to the CRUSADE score showed a significant increase in predicting risk of major bleeding in acute coronary syndrome patients. A re-evaluation of the association between dual anti-platelet (DAPT) and allogeneic blood transfusion is necessary. This will be done by the addition of DAPT as an extra predictive factor to the TRACK model, during external validation.
The negative association between mortality and transfusion products is well known. In addition, the related significant increase in hospital costs makes better perioperative hemostasis management crucial. Identifying cardiac surgery patients at risk for blood transfusion pre-operatively would aid clinicians in modifying the perioperative approach with goal the prevention of unnecessary allogeneic blood transfusion and the associated complications thereof.
Validating this model might aid clinicians in reducing allogeneic blood transfusions, transfusion complications and associated costs. Ultimately this might aid for development of patient specific transfusion strategies and new blood management protocols.
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 will be studied, as additional predictive factor, to the TRACK blood transfusion prediction model.
- Conditions
- Platelet Aggregation, Blood Transfusion
- Being tested
- TRACK-TCT
- Keywords
- External validation, Blood transfusion, P2Y12 Receptor Inhibitor, Prediction Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRACK-TCTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: TRACK-TCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Male vs Female
How does the performance of the model change in an all-male and all-female population.
Measured: 1 year
Post operative complication in patients that received a blood transfusion
Does allogeneic blood transfusion increase the risk of post-operative complications or thromboembolic events?
Measured: 1 year
Mortality difference in patients that received a blood transfusion
What is the difference in 30-day mortality between patients receiving allogeneic blood transfusions and patients that does not?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Nov 2022
- Primary completion30 Jun 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Platelet AggregationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renard Haumann, Medisch Spectrum Twente
- Investigators
- Frank R Halfwerk, MD PhD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581238
- Sponsor's protocol ID
- Protocol_TRACK-TCT_v 2.0
- Acronym
- TRACK-TCT
- Status last verified
- Mar 2024
- First submitted
- 12 Oct 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be made openly available in a repository according to FAIR (Findable, Accessible, Interoperable, Reproducible) guidelines.
Publications
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.
PubMed 23910533Raphael 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.
PubMed 31613811Task 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.
PubMed 29029990Karkouti 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.
PubMed 15383018Ranucci 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.
PubMed 19049749Khan 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.
PubMed 35634631Haumann 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. 2026 Jan;41(1):42-52. doi: 10.1177/02676591251334903. Epub 2025 Apr 19.
PubMed 40252042
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the TRACK Allogeneic Transfusion Model in a Dutch Adult Cardiac Surgery Population, and the Effect on Discriminative Ability When Adding Anti-platelet Therapy
- ClinicalTrials.gov ID
- NCT05581238
- Acronym / sponsor ID
- TRACK-TCT / Protocol_TRACK-TCT_v 2.0
- Conditions
- Platelet Aggregation, Blood Transfusion
- Keywords
- External validation, Blood transfusion, P2Y12 Receptor Inhibitor, Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,428 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiothoracic surgery is associated with increased perioperative blood loss and the need for allogeneic blood and blood product transfusions. This is due to three distinct factors, the invasive nature of the surgical procedures, the need for high dose anti-coagulation during extracorporeal circulation, and lastly the exposure of blood to the internal surface area of the heart-lung machine. Most cardiac patients use anti-platelet therapy before and after surgery, making hemostasis management in this specific patient population even more complex. European guidelines recommend administering anti-platelet therapy using Aspirin in combination with platelet receptor inhibitors such as Clopidogrel, Prasugrel or Ticagrelor, also known as dual anti-platelet therapy in patients with acute coronary syndrome.
Making distinct decisions regarding individual patient hemostasis management remains challenging. Decision making supported by prediction models, such as, EuroSCORE is well established in the cardiac surgery population. A few models pertaining specifically to allogeneic blood transfusion have been created and externally validated. Most of these prediction models perform reasonably well, predicting red blood cell transfusions with seventy-eighty percent accuracy, depending on the model and number of prediction factors used. Some are even excellent for predicting the chance of severe post-operative bleeding. As the transfusion of even one unit of allogeneic blood transfusion impacts mortality, the choice for the best feasible prediction model for routine clinical practice that reflects daily practice, uses a limited number of predictive factors, has a predictive capacity of more than seventy percent, and discriminates between risk groups for allogeneic blood transfusion is desirable.
Transfusion Risk and Clinical Knowledge (TRACK) model validation and optimization The TRACK model was developed more than ten years ago in an Italian adult cardiac surgery population. The decision to validate the TRACK model was based on its simplicity and relatively high predictive capacity, in comparison to other models with higher numbers of complex factors. This model has an allogeneic blood transfusion predictive capacity of seventy-two percent and uses a point system to divide patients into different risk groups, according to the total number of points allocated. During the derivation of this model, dual anti-platelet medication was included, but no significant association was found. In the twelve years since development, the popularity of dual anti-platelet medication used in acute coronary syndrome patients has significantly increased and its association with post-operative bleeding and allogeneic blood transfusion has been suggested.
Recent studies suggest that platelet activity may play a significant role in the prediction of post-operative bleeding, and one research group found that adding platelet activity to the CRUSADE score showed a significant increase in predicting risk of major bleeding in acute coronary syndrome patients. A re-evaluation of the association between dual anti-platelet (DAPT) and allogeneic blood transfusion is necessary. This will be done by the addition of DAPT as an extra predictive factor to the TRACK model, during external validation.
The negative association between mortality and transfusion products is well known. In addition, the related significant increase in hospital costs makes better perioperative hemostasis management crucial. Identifying cardiac surgery patients at risk for blood transfusion pre-operatively would aid clinicians in modifying the perioperative approach with goal the prevention of unnecessary allogeneic blood transfusion and the associated complications thereof.
Validating this model might aid clinicians in reducing allogeneic blood transfusions, transfusion complications and associated costs. Ultimately this might aid for development of patient specific transfusion strategies and new blood management protocols.
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 will be studied, as additional predictive factor, to the TRACK blood transfusion prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRACK | – | –External validation of TRACK prediction model with 5 variables: age, weight, sex, pre-op HCT, Type of surgery. |
| TRACK-TCT | – | Other: TRACK-TCTNew 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients receiving on-pump cardiac surgery
Key exclusion criteria (1 listed)
- Patients who opted out for reuse of their data for scientific purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRACK-TCTAn 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. | Other | TRACK-TCT |
Primary outcome
External validation TRACK blood prediction Model (TRACK)
Time frame: 1 year
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.
Evaluation of the change in predictive capacity when adding P2Y12 as extra variable (TRACK-TCT)
Time frame: 1 year
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.
3 secondary outcomes
Male vs Female
Time frame: 1 year
Post operative complication in patients that received a blood transfusion
Time frame: 1 year
Mortality difference in patients that received a blood transfusion
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 23910533Gorlinger 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.
- Background: PubMed 31613811Raphael 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.
- Background: PubMed 29029990Task 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.
- Background: PubMed 15383018Karkouti 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.
- Background: PubMed 19049749Ranucci 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.
- Background: PubMed 35634631Khan 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.
- Derived from this study: PubMed 40252042Haumann 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. 2026 Jan;41(1):42-52. doi: 10.1177/02676591251334903. Epub 2025 Apr 19.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be made openly available in a repository according to FAIR (Findable, Accessible, Interoperable, Reproducible) guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank R Halfwerk, MD PhD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Aggregation and Blood Transfusion, run by Medisch Spectrum Twente 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 1 inclusion and 1 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 7 Mar 2024. 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?
External validation TRACK blood prediction Model (TRACK) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05581238, which also lists 7 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 7 Mar 2024.