RECRUITING

Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients

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Conditions

HemorrhagePlatelets; DefectBleedingSurgical Blood Loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Efficacy and Safety of Extended Cold Stored Apheresis Platelets Versus Conventional Apheresis Platelets in Cardiac Surgery Patients

Quick Facts

Study Start:2022-02-21
Study Completion:2024-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05220787

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. Subject age is greater than or equal to 18 years of age.
  2. * 2. Subject can speak and read English.
  3. * 3. Subject weight is greater than 40 kg.
  4. * 4. Subject is scheduled for redo, triple valve, or complex aortic cardiac surgery with cardiopulmonary bypass.
  5. * 5. Subject has ability to comprehend and willingness to sign Informed Consent Form (ICF).
  6. * 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. * 7. Subject agrees to not participate in another interventional study during study participation.
  8. * 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.
  1. * 1. Subject has history of known repeated, severe transfusion reactions.
  2. * 2. Subject requires washed products, volume reduced products, or products with additive solution.
  3. * 3. Subject is planned to receive autologous or directed transfusions.
  4. * 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. * 5. Subject is thrombocytopenic (less than 100 x 103 platelets/μL) on most recent measurement.
  6. * 6. Subject is pregnant or breastfeeding.
  7. * 7. Subject is a prisoner
  8. * 8. Subject has active infection.
  9. * 9. Subject refuses blood products.
  10. * 10. Subject has a history of unprovoked deep vein thrombosis (DVT) or unprovoked pulmonary embolism (PE).
  11. * 11. Subject has previously been enrolled and received a study platelet transfusion.
  12. * 12. Subject has known bleeding diathesis (hemophilia, Von Willebrand Disease, or others)
  13. * 13. At discretion of subject's physician, Sub-Investigator (SI), or Principle Investigator (PI).

Contacts and Locations

Study Contact

Jeffrey Miles, M.S.
CONTACT
206-689-6285
jmiles@bloodworksnw.org
Pat Klotz, BSN
CONTACT
206-568-2238
pklotz@bloodworksnw.org

Principal Investigator

Moritz Stolla, MD
PRINCIPAL_INVESTIGATOR
Bloodworks Northwest

Study Locations (Sites)

Swedish Medical Center - Cherry Hill
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Moritz Stolla, MD

  • Moritz Stolla, MD, PRINCIPAL_INVESTIGATOR, Bloodworks Northwest

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-21
Study Completion Date2024-10-29

Study Record Updates

Study Start Date2022-02-21
Study Completion Date2024-10-29

Terms related to this study

Additional Relevant MeSH Terms

  • Hemorrhage
  • Platelets; Defect
  • Bleeding
  • Surgical Blood Loss