HemorrhagePhase 1/2CHASENCT05220787
Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients
A Phase 1/2 study testing Cold stored platelets in 100% plasma stored for 10-14 days and Room temperature stored platelets in 100% plasma stored for up to 7 days in people with Hemorrhage and Platelets; Defect, run by Moritz Stolla, MD at 1 site in United States.
Trial summary
This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients who are actively bleeding and require platelet transfusion. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemorrhage, Platelets; Defect, Bleeding
- What is being tested?
- Cold stored platelets in 100% plasma stored for 10-14 days and Room temperature stored platelets in 100% plasma stored for up to 7 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 29 Oct 2024
- Phase
- Phase 1/2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subject age is greater than or equal to 18 years of age.
- 2. Subject can speak and read English.
- 3. Subject weight is greater than 40 kg.
- 4. Subject is scheduled for redo, triple valve, or complex aortic cardiac surgery with cardiopulmonary bypass.
- 5. Subject has ability to comprehend and willingness to sign Informed Consent Form (ICF).
- 6. If female of childbearing potential, must have a negative pregnancy test and agree to use one of the following methods of contraception during the course of study participation: abstinence, intrauterine contraception device, hormonal method, or barrier method.
- 7. Subject agrees to not participate in another interventional study during study participation.
- 8. The clinical site can obtain both possible platelet products (CSP and RSP) as needed per the study protocol given the subject's anticipated surgery date.
Who cannot join
- 1. Subject has history of known repeated, severe transfusion reactions.
- 2. Subject requires washed products, volume reduced products, or products with additive solution.
- 3. Subject is planned to receive autologous or directed transfusions.
- 4. Subject has or is expected to require post-surgical ventricular assist device (VAD), hemodialysis, or extracorporeal membrane oxygenation (ECMO) within 24 hours of the Study Treatment Window.
- 5. Subject is thrombocytopenic (less than 100 x 103 platelets/μL) on most recent measurement.
- 6. Subject is pregnant or breastfeeding.
Show all 13Show fewer
- 7. Subject is a prisoner
- 8. Subject has active infection.
- 9. Subject refuses blood products.
- 10. Subject has a history of unprovoked deep vein thrombosis (DVT) or unprovoked pulmonary embolism (PE).
- 11. Subject has previously been enrolled and received a study platelet transfusion.
- 12. Subject has known bleeding diathesis (hemophilia, Von Willebrand Disease, or others)
- 13. At discretion of subject's physician, Sub-Investigator (SI), or Principle Investigator (PI).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Swedish Medical Center - Cherry Hill
Seattle, Washington, 98122
Inger Rasmussen, 206-215-3989, inger.rasmussen@swedish.org
About this study
Official title: Evaluation of Efficacy and Safety of Extended Cold Stored Apheresis Platelets Versus Conventional Apheresis Platelets in Cardiac Surgery Patients
This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients who are actively bleeding and require platelet transfusion.
Read the detailed description
Cardiac surgery featuring cardiopulmonary bypass (CPB) has a detrimental effect on platelet function. Contact with foreign surfaces causes a transient platelet dysfunction. The bleeding time is prolonged for the time on bypass and reverts to normal approximately one hour after cardiac surgery in uncomplicated cases. Hemorrhage following cardiac surgery with CPB can cause surgical re-exploration and increased mortality. The overall risk for surgical re-exploration is between 2.5-5%. Patients who undergo re-exploration due to excessive bleeding have a 2-6 fold increased mortality compared with non-bleeding patients. Storage of platelets at 1-6°C has the advantage of potentially prolonging storage times while reducing bacterial contamination. Room-temperature storage has led to a 5 day storage time limit since bacterial growth and septic reactions increase rapidly after 5-7 days. CSP were the standard of care in the 1960-70s. CSP were abandoned when a reduced platelet survival was observed in platelet radiolabeling studies. Nevertheless, CSP may have several advantages over RSP in the study population including a state of pre-activation and therefore a potentially superior hemostatic function. A small pilot trial investigating CSP in cardiac surgery patients in Norway found a non-significant trend towards improved bleeding control with CSP transfusions. However, data evaluating the in vivo efficacy of CSP is limited in scale and quality with mixed results. The investigators and others have shown that CSP have a superior function compared with RSP in vitro and more data are needed to clarify the relative efficacy of CSP in vivo. The investigators hypothesize that 1) CSP are more effective than RSP at reducing blood loss and improving platelet function in subjects actively bleeding due to cardiac surgery with cardiopulmonary bypass (CPB), and that 2) CSP are safe and do not lead to increased risks relative to RSP.
- Conditions
- Hemorrhage, Platelets; Defect, Bleeding, Surgical Blood Loss
- Being tested
- Cold stored platelets in 100% plasma stored for 10-14 days, Room temperature stored platelets in 100% plasma stored for up to 7 days
- Medical subject headings
- Hemorrhage, Blood Platelet Disorders, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold stored platelets in 100% plasma stored for 10-14 daysBiological
Subjects will receive cold stored platelets from the start of surgery until 24 hours after the end of surgery
Room temperature stored platelets in 100% plasma stored for up to 7 daysBiological
Subjects will receive room temperature stored platelets from the start of surgery until 24 hours after the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Cold stored platelets in 100% plasma stored for 10-14 days | Experimental | Cold stored apheresis platelets in 100% plasma stored for 10-14 days, maximum of up to three units (3x10^11/unit) from the start of surgery until 24 hours after the end of surgery Receives: Biological: Cold stored platelets in 100% plasma stored for 10-14 days |
| Room temperature stored platelets in 100% plasma stored for up to 7 days | Active comparator | Room temperature stored platelets in 100% plasma stored for up to 7 days, maximum of up to three units (3x10^11/unit) from the start of surgery until 24 hours after the end of surgery Receives: Biological: Room temperature stored platelets in 100% plasma stored for up to 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the recruitment and accrual into the study protocol.
Number of subjects screened and enrolled into the study protocol.
Measured: 24 hours following end of cardiac surgery
Secondary outcomes (11)
Total allogeneic blood units transfused (RBCs only, platelets only, plasma only, and composite of all three)
Number of units
Measured: Start of surgery to 24 hours after surgery
Chest tube output volume
volume of chest tube output measured in milliliters.
Measured: 24 hours after completion of surgery
Hemostatic agents administered
The total individual doses of hemostatic agents
Measured: 24 hours after completion of surgery
Number of subjects requiring surgical re-exploration due to uncontrolled bleeding
binary
Measured: 24 hours after completion of surgery
Number of subjects with evidence of new infection or sepsis
per protocol definition
Measured: Through post-op day 3
Number of subjects with evidence of a thrombotic event
per protocol definition
Measured: Through study completion, an average of 3 weeks.
Number of subjects with evidence of liver injury.
Maximum post-operative change from pre-surgical baseline within the first three days
Measured: Through post-op day 3
Hospital free days
Number of days out of the hospital.
Measured: Post-op through day 28.
ICU free days
Number of days out of the ICU
Measured: Post-op through day 28.
Ventilator free days
Number of days not on a ventilator.
Measured: post-op through day 28.
Mortality
To evaluate mortality at 28 days.
Measured: Post-op through day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start21 Feb 2022
- Primary completion29 Oct 2024 (estimated)
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to 1 of 2 treatment groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moritz Stolla, MD
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Moritz Stolla, MD, Bloodworks
- Investigators
- Moritz Stolla, MD, Principal investigator, Bloodworks Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220787
- Sponsor's protocol ID
- 2021-01
- Acronym
- CHASE
- Status last verified
- Jul 2023
- First submitted
- 11 Oct 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Extended Cold Stored Apheresis Platelets Versus Conventional Apheresis Platelets in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05220787
- Acronym / sponsor ID
- CHASE / 2021-01
- Conditions
- Hemorrhage, Platelets; Defect, Bleeding, Surgical Blood Loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Moritz Stolla, MDUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 29 Oct 2024 (estimated)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 2 Feb 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.
This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients who are actively bleeding and require platelet transfusion.
Detailed description
Cardiac surgery featuring cardiopulmonary bypass (CPB) has a detrimental effect on platelet function. Contact with foreign surfaces causes a transient platelet dysfunction. The bleeding time is prolonged for the time on bypass and reverts to normal approximately one hour after cardiac surgery in uncomplicated cases. Hemorrhage following cardiac surgery with CPB can cause surgical re-exploration and increased mortality. The overall risk for surgical re-exploration is between 2.5-5%. Patients who undergo re-exploration due to excessive bleeding have a 2-6 fold increased mortality compared with non-bleeding patients. Storage of platelets at 1-6°C has the advantage of potentially prolonging storage times while reducing bacterial contamination. Room-temperature storage has led to a 5 day storage time limit since bacterial growth and septic reactions increase rapidly after 5-7 days. CSP were the standard of care in the 1960-70s. CSP were abandoned when a reduced platelet survival was observed in platelet radiolabeling studies. Nevertheless, CSP may have several advantages over RSP in the study population including a state of pre-activation and therefore a potentially superior hemostatic function. A small pilot trial investigating CSP in cardiac surgery patients in Norway found a non-significant trend towards improved bleeding control with CSP transfusions. However, data evaluating the in vivo efficacy of CSP is limited in scale and quality with mixed results. The investigators and others have shown that CSP have a superior function compared with RSP in vitro and more data are needed to clarify the relative efficacy of CSP in vivo. The investigators hypothesize that 1) CSP are more effective than RSP at reducing blood loss and improving platelet function in subjects actively bleeding due to cardiac surgery with cardiopulmonary bypass (CPB), and that 2) CSP are safe and do not lead to increased risks relative to RSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be assigned to 1 of 2 treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Cold stored platelets in 100% plasma stored for 10-14 days | Experimental | Biological: Cold stored platelets in 100% plasma stored for 10-14 daysCold stored apheresis platelets in 100% plasma stored for 10-14 days, maximum of up to three units (3x10^11/unit) from the start of surgery until 24 hours after the end of surgery |
| Room temperature stored platelets in 100% plasma stored for up to 7 days | Active comparator | Biological: Room temperature stored platelets in 100% plasma stored for up to 7 daysRoom temperature stored platelets in 100% plasma stored for up to 7 days, maximum of up to three units (3x10^11/unit) from the start of surgery until 24 hours after the end of surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Subject age is greater than or equal to 18 years of age.
- 2. Subject can speak and read English.
- 3. Subject weight is greater than 40 kg.
- 4. Subject is scheduled for redo, triple valve, or complex aortic cardiac surgery with cardiopulmonary bypass.
- 5. Subject has ability to comprehend and willingness to sign Informed Consent Form (ICF).
Key exclusion criteria (13 listed)
- 1. Subject has history of known repeated, severe transfusion reactions.
- 2. Subject requires washed products, volume reduced products, or products with additive solution.
- 3. Subject is planned to receive autologous or directed transfusions.
- 4. Subject has or is expected to require post-surgical ventricular assist device (VAD), hemodialysis, or extracorporeal membrane oxygenation (ECMO) within 24 hours of the Study Treatment Window.
- 5. Subject is thrombocytopenic (less than 100 x 103 platelets/μL) on most recent measurement.
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 |
|---|---|---|
| Cold stored platelets in 100% plasma stored for 10-14 daysSubjects will receive cold stored platelets from the start of surgery until 24 hours after the end of surgery | Biological | Cold stored platelets in 100% plasma stored for 10-14 days |
| Room temperature stored platelets in 100% plasma stored for up to 7 daysSubjects will receive room temperature stored platelets from the start of surgery until 24 hours after the end of surgery | Biological | Room temperature stored platelets in 100% plasma stored for up to 7 days |
Primary outcome
Feasibility of the recruitment and accrual into the study protocol.
Time frame: 24 hours following end of cardiac surgery
Number of subjects screened and enrolled into the study protocol.
11 secondary outcomes
Total allogeneic blood units transfused (RBCs only, platelets only, plasma only, and composite of all three)
Time frame: Start of surgery to 24 hours after surgery
Chest tube output volume
Time frame: 24 hours after completion of surgery
Hemostatic agents administered
Time frame: 24 hours after completion of surgery
Number of subjects requiring surgical re-exploration due to uncontrolled bleeding
Time frame: 24 hours after completion of surgery
Number of subjects with evidence of new infection or sepsis
Time frame: Through post-op day 3
Number of subjects with evidence of a thrombotic event
Time frame: Through study completion, an average of 3 weeks.
Number of subjects with evidence of liver injury.
Time frame: Through post-op day 3
Hospital free days
Time frame: Post-op through day 28.
ICU free days
Time frame: Post-op through day 28.
Ventilator free days
Time frame: post-op through day 28.
Mortality
Time frame: Post-op through day 28.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
Moritz Stolla, MD principal investigator
Bloodworks Northwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cold stored platelets in 100% plasma stored for 10-14 days and Room temperature stored platelets in 100% plasma stored for up to 7 days in people with Hemorrhage and Platelets; Defect, run by Moritz Stolla, MD 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Miles, M.S. (206-689-6285, jmiles@bloodworksnw.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the recruitment and accrual into the study protocol. (time frame: 24 hours following end of cardiac surgery). 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 27 Jul 2023.