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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05220787
Other study ID # 2021-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 21, 2022
Est. completion date October 29, 2024

Study information

Verified date July 2023
Source Bloodworks
Contact Jeffrey Miles, M.S.
Phone 206-689-6285
Email jmiles@bloodworksnw.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 29, 2024
Est. primary completion date October 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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).

Study Design


Intervention

Biological:
Cold stored platelets in 100% plasma stored for 10-14 days
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 days
Subjects will receive room temperature stored platelets from the start of surgery until 24 hours after the end of surgery

Locations

Country Name City State
United States Swedish Medical Center - Cherry Hill Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Moritz Stolla, MD United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the recruitment and accrual into the study protocol. Number of subjects screened and enrolled into the study protocol. 24 hours following end of cardiac surgery
Secondary Total allogeneic blood units transfused (RBCs only, platelets only, plasma only, and composite of all three) Number of units Start of surgery to 24 hours after surgery
Secondary Chest tube output volume volume of chest tube output measured in milliliters. 24 hours after completion of surgery
Secondary Hemostatic agents administered The total individual doses of hemostatic agents 24 hours after completion of surgery
Secondary Number of subjects requiring surgical re-exploration due to uncontrolled bleeding binary 24 hours after completion of surgery
Secondary Number of subjects with evidence of new infection or sepsis per protocol definition Through post-op day 3
Secondary Number of subjects with evidence of a thrombotic event per protocol definition Through study completion, an average of 3 weeks.
Secondary Number of subjects with evidence of liver injury. Maximum post-operative change from pre-surgical baseline within the first three days Through post-op day 3
Secondary Hospital free days Number of days out of the hospital. Post-op through day 28.
Secondary ICU free days Number of days out of the ICU Post-op through day 28.
Secondary Ventilator free days Number of days not on a ventilator. post-op through day 28.
Secondary Mortality To evaluate mortality at 28 days. Post-op through day 28.
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