Back to resultsExtended Cold Stored Apheresis Platelets in Cardiac Surgery Patients (CHASE)
Primary Purpose
Hemorrhage, Platelets; Defect, Bleeding
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cold stored platelets in 100% plasma stored for 10-14 days
Room temperature stored platelets in 100% plasma stored for up to 7 days
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Sites / Locations
- Swedish Medical Center - Cherry HillRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cold stored platelets in 100% plasma stored for 10-14 days
Room temperature stored platelets in 100% plasma stored for up to 7 days
Arm Description
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
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
Outcomes
Primary Outcome Measures
Feasibility of the recruitment and accrual into the study protocol.
Number of subjects screened and enrolled into the study protocol.
Secondary Outcome Measures
Total allogeneic blood units transfused (RBCs only, platelets only, plasma only, and composite of all three)
Number of units
Chest tube output volume
volume of chest tube output measured in milliliters.
Hemostatic agents administered
The total individual doses of hemostatic agents
Number of subjects requiring surgical re-exploration due to uncontrolled bleeding
binary
Number of subjects with evidence of new infection or sepsis
per protocol definition
Number of subjects with evidence of a thrombotic event
per protocol definition
Number of subjects with evidence of liver injury.
Maximum post-operative change from pre-surgical baseline within the first three days
Hospital free days
Number of days out of the hospital.
ICU free days
Number of days out of the ICU
Ventilator free days
Number of days not on a ventilator.
Mortality
To evaluate mortality at 28 days.
Full Information
NCT ID
NCT05220787
First Posted
October 11, 2021
Last Updated
July 26, 2023
Sponsor
Moritz Stolla, MD
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT05220787
Brief Title
Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients
Acronym
CHASE
Official Title
Evaluation of Efficacy and Safety of Extended Cold Stored Apheresis Platelets Versus Conventional Apheresis Platelets in Cardiac Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
October 29, 2024 (Anticipated)
Study Completion Date
October 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moritz Stolla, MD
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Platelets; Defect, Bleeding, Surgical Blood Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be assigned to 1 of 2 treatment groups.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cold stored platelets in 100% plasma stored for 10-14 days
Arm Type
Experimental
Arm Description
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
Arm Title
Room temperature stored platelets in 100% plasma stored for up to 7 days
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Cold stored platelets in 100% plasma stored for 10-14 days
Intervention Description
Subjects will receive cold stored platelets from the start of surgery until 24 hours after the end of surgery
Intervention Type
Biological
Intervention Name(s)
Room temperature stored platelets in 100% plasma stored for up to 7 days
Intervention Description
Subjects will receive room temperature stored platelets from the start of surgery until 24 hours after the end of surgery
Primary Outcome Measure Information:
Title
Feasibility of the recruitment and accrual into the study protocol.
Description
Number of subjects screened and enrolled into the study protocol.
Time Frame
24 hours following end of cardiac surgery
Secondary Outcome Measure Information:
Title
Total allogeneic blood units transfused (RBCs only, platelets only, plasma only, and composite of all three)
Description
Number of units
Time Frame
Start of surgery to 24 hours after surgery
Title
Chest tube output volume
Description
volume of chest tube output measured in milliliters.
Time Frame
24 hours after completion of surgery
Title
Hemostatic agents administered
Description
The total individual doses of hemostatic agents
Time Frame
24 hours after completion of surgery
Title
Number of subjects requiring surgical re-exploration due to uncontrolled bleeding
Description
binary
Time Frame
24 hours after completion of surgery
Title
Number of subjects with evidence of new infection or sepsis
Description
per protocol definition
Time Frame
Through post-op day 3
Title
Number of subjects with evidence of a thrombotic event
Description
per protocol definition
Time Frame
Through study completion, an average of 3 weeks.
Title
Number of subjects with evidence of liver injury.
Description
Maximum post-operative change from pre-surgical baseline within the first three days
Time Frame
Through post-op day 3
Title
Hospital free days
Description
Number of days out of the hospital.
Time Frame
Post-op through day 28.
Title
ICU free days
Description
Number of days out of the ICU
Time Frame
Post-op through day 28.
Title
Ventilator free days
Description
Number of days not on a ventilator.
Time Frame
post-op through day 28.
Title
Mortality
Description
To evaluate mortality at 28 days.
Time Frame
Post-op through day 28.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Miles, M.S.
Phone
206-689-6285
Email
jmiles@bloodworksnw.org
First Name & Middle Initial & Last Name or Official Title & Degree
Pat Klotz, BSN
Phone
206-568-2238
Email
pklotz@bloodworksnw.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moritz Stolla, MD
Organizational Affiliation
Bloodworks Northwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center - Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inger Rasmussen
Phone
206-215-3989
Email
inger.rasmussen@swedish.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients
We'll reach out to this number within 24 hrs