Cardiopulmonary Bypass SurgeryPhase 4NCT06535360
Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion
A Phase 4 study testing Platelet transfusion in people with Cardiopulmonary Bypass Surgery, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass Surgery
- What is being tested?
- Platelet transfusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 31 May 2023
- Phase
- Phase 4
- 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
- Preoperative evaluation for risk of transfusion: platelet count < 200,000/mcl, OR anticipated time on cardiopulmonary bypass > 90 min, OR complex cardiac surgery, OR use of preoperative antiplatelet therapy within 3-5 days of surgery.
Who cannot join
- Patient that lack the ability to consent
- Patients with the diagnosis of idiopathic thrombocytopenia purpura,
- Patient with the diagnosis of heparin-induced thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass
This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.
Read the detailed description
The safety and efficacy of pathogen reduced (PRT) platelets (PLTs) have been investigated in several controlled clinical studies. Most of these clinical studies evaluated the efficacy of PRT PLTs during prophylactic transfusion evaluating post-transfusion platelet count increments, rather than platelet function during bleeding episodes. During massive transfusion events and immediate resuscitation, PLT transfusion is recognized as an important determinant of a positive patient outcome. PLT transfusion is important to control bleeding in patients undergoing cardiac surgery on cardiopulmonary bypass because cardiopulmonary bypass alters platelet function. Thus, transfusion of functional platelets is required to control bleeding post-operatively. In this context, the investigators propose to investigate whether efficient hemostasis associated with platelet transfusion differs with the use of pathogen reduced PRT PLTs compared to non-pathogen reduced PLTs that are suspended in platelet additive solution.
- Conditions
- Cardiopulmonary Bypass Surgery
- Being tested
- Platelet transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet transfusionBiological
platelet administration through intravenous access
| Study group | Role | What they receive |
|---|---|---|
| PRT PLTs stored in PAS | Experimental | FDA approved and already used in this patient population tested for non-inferiority Receives: Biological: Platelet transfusion |
| Non-PRT PLTs stored in platelet additive solution (PAS) | Active comparator | FDA approved and already used in this patient population Receives: Biological: Platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Amplitude (MA) of thromboelastography (TEG)
ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)
Measured: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion
Secondary outcomes (5)
Chest Tube Drainage
The volume in ml of chest tube drainage during the first 24 hours post surgery
Measured: 24 hours
Red blood cell units Transfused
number of red blood cell units transfused
Measured: Within the first 24 Hrs Following Surgery
Platelet Units Transfused
number of platelet units transfused
Measured: Within the first 24 Hrs Following Surgery
Cryoprecipitate Units Transfused
number of Cryoprecipitate Units Transfused
Measured: Within the first 24 Hrs Following Surgery
Plasma Units Transfused
number of plasma units transfused
Measured: Within the first 24 Hrs Following Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magali Fontaine, University of Maryland, Baltimore
- Investigators
- Magali Fontaine, MD, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535360
- Sponsor's protocol ID
- HP-00088613
- Status last verified
- Aug 2024
- First submitted
- 6 May 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06535360
- Acronym / sponsor ID
- HP-00088613
- Conditions
- Cardiopulmonary Bypass Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 2 Aug 2024 (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.
This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.
Detailed description
The safety and efficacy of pathogen reduced (PRT) platelets (PLTs) have been investigated in several controlled clinical studies. Most of these clinical studies evaluated the efficacy of PRT PLTs during prophylactic transfusion evaluating post-transfusion platelet count increments, rather than platelet function during bleeding episodes. During massive transfusion events and immediate resuscitation, PLT transfusion is recognized as an important determinant of a positive patient outcome. PLT transfusion is important to control bleeding in patients undergoing cardiac surgery on cardiopulmonary bypass because cardiopulmonary bypass alters platelet function. Thus, transfusion of functional platelets is required to control bleeding post-operatively. In this context, the investigators propose to investigate whether efficient hemostasis associated with platelet transfusion differs with the use of pathogen reduced PRT PLTs compared to non-pathogen reduced PLTs that are suspended in platelet additive solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRT PLTs stored in PAS | Experimental | Biological: Platelet transfusionFDA approved and already used in this patient population tested for non-inferiority |
| Non-PRT PLTs stored in platelet additive solution (PAS) | Active comparator | Biological: Platelet transfusionFDA approved and already used in this patient population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Preoperative evaluation for risk of transfusion: platelet count < 200,000/mcl, OR anticipated time on cardiopulmonary bypass > 90 min, OR complex cardiac surgery, OR use of preoperative antiplatelet therapy within 3-5 days of surgery.
Key exclusion criteria (3 listed)
- Patient that lack the ability to consent
- Patients with the diagnosis of idiopathic thrombocytopenia purpura,
- Patient with the diagnosis of heparin-induced thrombocytopenia.
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 |
|---|---|---|
| Platelet transfusionplatelet administration through intravenous access | Biological | Non-PRT PLTs stored in platelet additive solution (PAS), PRT PLTs stored in PAS |
Primary outcome
Change in Maximum Amplitude (MA) of thromboelastography (TEG)
Time frame: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion
ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)
5 secondary outcomes
Chest Tube Drainage
Time frame: 24 hours
Red blood cell units Transfused
Time frame: Within the first 24 Hrs Following Surgery
Platelet Units Transfused
Time frame: Within the first 24 Hrs Following Surgery
Cryoprecipitate Units Transfused
Time frame: Within the first 24 Hrs Following Surgery
Plasma Units Transfused
Time frame: Within the first 24 Hrs Following Surgery
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 6 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Magali Fontaine, MD, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet transfusion in people with Cardiopulmonary Bypass Surgery, run by University of Maryland, Baltimore at 1 site in United States.
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 3 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 6 Aug 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Maximum Amplitude (MA) of thromboelastography (TEG) (time frame: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.