Recruiting
Phase 1
Phase 2

Apheresis Platelets

Sponsor:

Moritz Stolla, MD

Code:

NCT05220787

Conditions

Hemorrhage

Platelets; Defect

Bleeding

Surgical Blood Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cold stored platelets in 100% plasma stored for 10-14 days

Room temperature stored platelets in 100% plasma stored for up to 7 days

Study Details

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.

Conditions

Hemorrhage

Platelets; Defect

Bleeding

Surgical Blood Loss

Study ID

NCT05220787

Start date

Feb 21, 2022

Status verified date

Jul, 2023

Completion date

Oct 29, 2024

Anticipated

Primary completion date

Oct 29, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cold stored platelets in 100% plasma stored for 10-14 days

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

active comparator: Room temperature stored platelets in 100% plasma stored for up to 7 days

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

Interventions

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

Primary outcome measure

  • Feasibility of the recruitment and accrual into the study protocol. [ Time Frame: 24 hours following end of cardiac surgery ]

Central Contacts and Locations

Central contacts

Jeffrey Miles, M.S.

206-689-6285jmiles@bloodworksnw.org

Pat Klotz, BSN

206-568-2238pklotz@bloodworksnw.org

Locations

Swedish Medical Center - Cherry Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Inger Rasmussen

206-215-3989inger.rasmussen@swedish.org

More Information

Sponsor

Moritz Stolla, MD

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Moritz Stolla, MD on 2023-07-27.