Platelet DysfunctionNCT05588011
Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass
A study testing Terumo and LivaNova in people with Platelet Dysfunction and Cardiopulmonary Bypass, run by BRADEN DULONG at 1 site in Canada.
Trial summary
Open-heart surgery requires temporarily stopping the heart and lungs and diverting the patient's blood to an outside system that takes over the function of the heart and lungs. This is possible through the use of cardiopulmonary bypass (CPB) which diverts blood, through plastic tubing, to a heart-lung machine which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Dysfunction, Cardiopulmonary Bypass
- What is being tested?
- Terumo and LivaNova
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 7 Oct 2022to 31 Oct 2025
- 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
- Scheduled for non emergent cardiac surgery
- Anticipated long CPB time (Multi-vessel CABG, multi-valve surgeries, or combined CABG and valve procedures)
Who cannot join
- Pregnancy
- Age under 18 years on the surgery date
- Weight less than 60kg
- Any known pre-existing bleeding disorder
- Inability to provide informed consent
- Pre-existing abnormal fibrinogen level (normal: 1.8-4.7g/l)
Show all 18Show fewer
- Significant liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
- INR > 1.4
- PTT greater than 38 (off IV heparin for 12h prior to testing)
- Direct oral anticoagulant (DOAC) use within 72h preoperatively
- Significant renal disease (eGFR < 50)
- Emergency surgery
- Intake of anti-platelet drugs (including ticagrelor and Plavix but excluding ASA) within three days (72h) preoperatively
- Anemia (Hb < 110)
- Deep vein thrombosis (DVT) (within 3 months prior to OR)
- Pulmonary embolism (within 3 months prior to OR)
- Stroke (within 3 months prior to OR)
- Planned hypothermia below 28 degrees Celsius.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Halifax Infirmary site, Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H3A7
About this study
Open-heart surgery requires temporarily stopping the heart and lungs and diverting the patient's blood to an outside system that takes over the function of the heart and lungs. This is possible through the use of cardiopulmonary bypass (CPB) which diverts blood, through plastic tubing, to a heart-lung machine which includes an oxygenator. The external oxygenator works as an artificial lung. This allows cardiac surgeons to operate in a field that is free of blood, while the patient's body continues to receive healthy blood.
CPB is an advanced medical technology that allows for heart surgeries, such as coronary artery bypass, heart valve surgery, and procedures involving major blood vessels. It is recognized that there are many risks associated with its use, including microscopic stress exerted on blood components by the oxygenator and tubing, which can lead to irreversible damage to the blood cells. This effect can contribute to bleeding during and after surgery. This type of bleeding can be difficult to monitor and treat, especially given the limited access to point-of-care blood testing to inform clinicians on what part of the blood is failing to function properly.
The investigators will use a point-of-care machine called Plateletworks to test the function of platelets during surgeries which require CPB. Platelets are an important part of blood that help stop bleeding by forming clots. At the investigators' institution two oxygenators are currently used interchangeably. These oxygenators have different properties that may impact how platelets function. This project will help determine if using a higher pressure oxygenator increases the risk of patients bleeding. Additionally, the investigators will compare the platelet data from Plateletworks to data collected from rotational thromboelastometry (ROTEM). This will yield valuable data about commonly used oxygenators and tests which can ultimately improve patient care.
- Conditions
- Platelet Dysfunction, Cardiopulmonary Bypass
- Being tested
- Terumo, LivaNova
- Keywords
- Rotem, Plateletworks, Cardiopulmonary Bypass, Platelets, Platelet function, Oxygenator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerumoDevice
A low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass.
LivaNovaDevice
A high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| LivaNova Inspire | Active comparator | A high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass. Receives: Device: LivaNova |
| Terumo | Active comparator | A low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass. Receives: Device: Terumo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plateletworks change in functional platelets
Change in functional platelets during cardiopulmonary bypass as measure by Plateletworks. ((Functional Platelets start - Functional Platelets end) / Functional Platelets start) *100%.
Measured: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
Plateletworks functional platelet count
Functional platelet count at the end of cardiopulmonary bypass as measured by Plateletworks.
Measured: 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Percentage of platelets which are functional at the end of cardiopulmonary bypass
Percentage of platelets which are functional at the end of cardiopulmonary bypass as measured by Plateletworks.
Measured: 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Secondary outcomes (1)
ROTEM change in functional platelets
ROTEM platelet function = EXTEM A10 - FIBTEM A10. ROTEM change in functional platelets = ((ROTEM Functional Platelets start - ROTEM Functional Platelets end) / ROTEM Functional Platelets start) *100%.
Measured: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start7 Oct 2022
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Platelet DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- BRADEN DULONG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BRADEN DULONG, Nova Scotia Health Authority
- Investigators
- Braden Dulong, MD, Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588011
- Sponsor's protocol ID
- NSH REB# 1027560
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 29029990Despotis G, Eby C, Lublin DM. A review of transfusion risks and optimal management of perioperative bleeding with cardiac surgery. Transfusion. 2008 Mar;48(1 Suppl):2S-30S. doi: 10.1111/j.1537-2995.2007.01573.x. No abstract available.
PubMed 18302579Hardwick RA, Hellums JD, Peterson DM, Moake JL, Olson JD. The effect of PGI2 and theophylline on the response of platelets subjected to shear stress. Blood. 1981 Oct;58(4):678-81.
PubMed 7023570Karkouti K, McCluskey SA, Callum J, Freedman J, Selby R, Timoumi T, Roy D, Rao V. Evaluation of a novel transfusion algorithm employing point-of-care coagulation assays in cardiac surgery: a retrospective cohort study with interrupted time-series analysis. Anesthesiology. 2015 Mar;122(3):560-70. doi: 10.1097/ALN.0000000000000556.
PubMed 25485470Karkouti K, Callum J, Wijeysundera DN, Rao V, Crowther M, Grocott HP, Pinto R, Scales DC; TACS Investigators. Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial. Circulation. 2016 Oct 18;134(16):1152-1162. doi: 10.1161/CIRCULATIONAHA.116.023956. Epub 2016 Sep 21.
PubMed 27654344Kaufman RM, Djulbegovic B, Gernsheimer T, Kleinman S, Tinmouth AT, Capocelli KE, Cipolle MD, Cohn CS, Fung MK, Grossman BJ, Mintz PD, O'Malley BA, Sesok-Pizzini DA, Shander A, Stack GE, Webert KE, Weinstein R, Welch BG, Whitman GJ, Wong EC, Tobian AA; AABB. Platelet transfusion: a clinical practice guideline from the AABB. Ann Intern Med. 2015 Feb 3;162(3):205-13. doi: 10.7326/M14-1589.
PubMed 25383671Koch CG, Li L, Duncan AI, Mihaljevic T, Loop FD, Starr NJ, Blackstone EH. Transfusion in coronary artery bypass grafting is associated with reduced long-term survival. Ann Thorac Surg. 2006 May;81(5):1650-7. doi: 10.1016/j.athoracsur.2005.12.037.
PubMed 16631651Kwapisz MM, Kent B, DiQuinzio C, LeGare JF, Garnett S, Swyer W, Whynot S, Mingo H, Scheffler M. The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery. Acta Anaesthesiol Scand. 2020 May;64(5):602-612. doi: 10.1111/aas.13540. Epub 2020 Jan 17.
PubMed 31889306Maquelin KN, Berckmans RJ, Nieuwland R, Schaap MC, ten Have K, Eijsman L, Sturk A. Disappearance of glycoprotein Ib from the platelet surface in pericardial blood during cardiopulmonary bypass. J Thorac Cardiovasc Surg. 1998 May;115(5):1160-5. doi: 10.1016/s0022-5223(98)70416-7.
PubMed 9605086Transfusion of Red Blood Cells, Fresh Frozen Plasma, or Platelets Is Associated With Mortality and Infection After Cardiac Surgery in a Dose-Dependent Manner. Anesth Analg. 2020 Feb;130(2):e32. doi: 10.1213/ANE.0000000000004528.
PubMed 31702696Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G; Surgical and Clinical Outcome Research (SCORE) Group. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):478-85. doi: 10.1016/j.athoracsur.2013.03.015. Epub 2013 May 11.
PubMed 23673069Raphael 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 31613811Stanzel RD, Henderson M. Clinical evaluation of contemporary oxygenators. Perfusion. 2016 Jan;31(1):15-25. doi: 10.1177/0267659115604709. Epub 2015 Sep 25.
PubMed 26407816Weerasinghe A, Taylor KM. The platelet in cardiopulmonary bypass. Ann Thorac Surg. 1998 Dec;66(6):2145-52. doi: 10.1016/s0003-4975(98)00749-8.
PubMed 9930521
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05588011
- Acronym / sponsor ID
- NSH REB# 1027560
- Conditions
- Platelet Dysfunction, Cardiopulmonary Bypass
- Keywords
- Rotem, Plateletworks, Cardiopulmonary Bypass, Platelets, Platelet function, Oxygenator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- BRADEN DULONGUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 20 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.
Open-heart surgery requires temporarily stopping the heart and lungs and diverting the patient's blood to an outside system that takes over the function of the heart and lungs. This is possible through the use of cardiopulmonary bypass (CPB) which diverts blood, through plastic tubing, to a heart-lung machine which includes an oxygenator. The external oxygenator works as an artificial lung. This allows cardiac surgeons to operate in a field that is free of blood, while the patient's body continues to receive healthy blood.
CPB is an advanced medical technology that allows for heart surgeries, such as coronary artery bypass, heart valve surgery, and procedures involving major blood vessels. It is recognized that there are many risks associated with its use, including microscopic stress exerted on blood components by the oxygenator and tubing, which can lead to irreversible damage to the blood cells. This effect can contribute to bleeding during and after surgery. This type of bleeding can be difficult to monitor and treat, especially given the limited access to point-of-care blood testing to inform clinicians on what part of the blood is failing to function properly.
The investigators will use a point-of-care machine called Plateletworks to test the function of platelets during surgeries which require CPB. Platelets are an important part of blood that help stop bleeding by forming clots. At the investigators' institution two oxygenators are currently used interchangeably. These oxygenators have different properties that may impact how platelets function. This project will help determine if using a higher pressure oxygenator increases the risk of patients bleeding. Additionally, the investigators will compare the platelet data from Plateletworks to data collected from rotational thromboelastometry (ROTEM). This will yield valuable data about commonly used oxygenators and tests which can ultimately improve patient care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LivaNova Inspire | Active comparator | Device: LivaNovaA high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass. |
| Terumo | Active comparator | Device: TerumoA low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for non emergent cardiac surgery
- Anticipated long CPB time (Multi-vessel CABG, multi-valve surgeries, or combined CABG and valve procedures)
Key exclusion criteria (18 listed)
- Pregnancy
- Age under 18 years on the surgery date
- Weight less than 60kg
- Any known pre-existing bleeding disorder
- Inability to provide informed consent
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 |
|---|---|---|
| TerumoA low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass. | Device | Terumo |
| LivaNovaA high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass. | Device | LivaNova Inspire |
Primary outcome
Plateletworks change in functional platelets
Time frame: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
Change in functional platelets during cardiopulmonary bypass as measure by Plateletworks. ((Functional Platelets start - Functional Platelets end) / Functional Platelets start) *100%.
Plateletworks functional platelet count
Time frame: 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Functional platelet count at the end of cardiopulmonary bypass as measured by Plateletworks.
Percentage of platelets which are functional at the end of cardiopulmonary bypass
Time frame: 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Percentage of platelets which are functional at the end of cardiopulmonary bypass as measured by Plateletworks.
1 secondary outcome
ROTEM change in functional platelets
Time frame: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
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 15 Apr 2026.
- 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 18302579Despotis G, Eby C, Lublin DM. A review of transfusion risks and optimal management of perioperative bleeding with cardiac surgery. Transfusion. 2008 Mar;48(1 Suppl):2S-30S. doi: 10.1111/j.1537-2995.2007.01573.x. No abstract available.
- Background: PubMed 7023570Hardwick RA, Hellums JD, Peterson DM, Moake JL, Olson JD. The effect of PGI2 and theophylline on the response of platelets subjected to shear stress. Blood. 1981 Oct;58(4):678-81.
- Background: PubMed 25485470Karkouti K, McCluskey SA, Callum J, Freedman J, Selby R, Timoumi T, Roy D, Rao V. Evaluation of a novel transfusion algorithm employing point-of-care coagulation assays in cardiac surgery: a retrospective cohort study with interrupted time-series analysis. Anesthesiology. 2015 Mar;122(3):560-70. doi: 10.1097/ALN.0000000000000556.
- Background: PubMed 27654344Karkouti K, Callum J, Wijeysundera DN, Rao V, Crowther M, Grocott HP, Pinto R, Scales DC; TACS Investigators. Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial. Circulation. 2016 Oct 18;134(16):1152-1162. doi: 10.1161/CIRCULATIONAHA.116.023956. Epub 2016 Sep 21.
- Background: PubMed 25383671Kaufman RM, Djulbegovic B, Gernsheimer T, Kleinman S, Tinmouth AT, Capocelli KE, Cipolle MD, Cohn CS, Fung MK, Grossman BJ, Mintz PD, O'Malley BA, Sesok-Pizzini DA, Shander A, Stack GE, Webert KE, Weinstein R, Welch BG, Whitman GJ, Wong EC, Tobian AA; AABB. Platelet transfusion: a clinical practice guideline from the AABB. Ann Intern Med. 2015 Feb 3;162(3):205-13. doi: 10.7326/M14-1589.
- Background: PubMed 16631651Koch CG, Li L, Duncan AI, Mihaljevic T, Loop FD, Starr NJ, Blackstone EH. Transfusion in coronary artery bypass grafting is associated with reduced long-term survival. Ann Thorac Surg. 2006 May;81(5):1650-7. doi: 10.1016/j.athoracsur.2005.12.037.
- Background: PubMed 31889306Kwapisz MM, Kent B, DiQuinzio C, LeGare JF, Garnett S, Swyer W, Whynot S, Mingo H, Scheffler M. The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery. Acta Anaesthesiol Scand. 2020 May;64(5):602-612. doi: 10.1111/aas.13540. Epub 2020 Jan 17.
- Background: PubMed 9605086Maquelin KN, Berckmans RJ, Nieuwland R, Schaap MC, ten Have K, Eijsman L, Sturk A. Disappearance of glycoprotein Ib from the platelet surface in pericardial blood during cardiopulmonary bypass. J Thorac Cardiovasc Surg. 1998 May;115(5):1160-5. doi: 10.1016/s0022-5223(98)70416-7.
- Background: PubMed 31702696Transfusion of Red Blood Cells, Fresh Frozen Plasma, or Platelets Is Associated With Mortality and Infection After Cardiac Surgery in a Dose-Dependent Manner. Anesth Analg. 2020 Feb;130(2):e32. doi: 10.1213/ANE.0000000000004528.
- Background: PubMed 23673069Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G; Surgical and Clinical Outcome Research (SCORE) Group. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):478-85. doi: 10.1016/j.athoracsur.2013.03.015. Epub 2013 May 11.
- 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.
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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.
Braden Dulong, MD principal investigator
Nova Scotia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terumo and LivaNova in people with Platelet Dysfunction and Cardiopulmonary Bypass, run by BRADEN DULONG at 1 site in Canada.
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 2 inclusion and 18 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 15 Apr 2026. 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 Canada. 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?
Plateletworks change in functional platelets (time frame: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)). The study lists 3 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 NCT05588011, which also lists 14 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 15 Apr 2026.