Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients

NCT05220787 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 2021-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Total allogeneic blood units transfused (RBCs only, platelets only, plasma only, and composite of all three)

  Start of surgery to 24 hours after surgery

• Chest tube output volume

  24 hours after completion of surgery

• Hemostatic agents administered

  24 hours after completion of surgery

• Number of subjects requiring surgical re-exploration due to uncontrolled bleeding

  24 hours after completion of surgery

• Number of subjects with evidence of new infection or sepsis

  Through post-op day 3

Study Arms (2)

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

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

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

Interventions

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

Subjects will receive cold stored platelets from the start of surgery until 24 hours after the end of surgery

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

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

Subjects will receive room temperature 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject age is greater than or equal to 18 years of age.
• \. Subject can speak and read English.
• \. Subject weight is greater than 40 kg.
• \. Subject is scheduled for redo, triple valve, or complex aortic cardiac surgery with cardiopulmonary bypass.
• \. Subject has ability to comprehend and willingness to sign Informed Consent Form (ICF).
• \. 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.
• \. Subject agrees to not participate in another interventional study during study participation.
• \. 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.

You may not qualify if:

• \. Subject has history of known repeated, severe transfusion reactions.
• \. Subject requires washed products, volume reduced products, or products with additive solution.
• \. Subject is planned to receive autologous or directed transfusions.
• \. 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.
• \. Subject is thrombocytopenic (less than 100 x 103 platelets/μL) on most recent measurement.
• \. Subject is pregnant or breastfeeding.
• \. Subject is a prisoner
• \. Subject has active infection.
• \. Subject refuses blood products.
• \. Subject has a history of unprovoked deep vein thrombosis (DVT) or unprovoked pulmonary embolism (PE).
• \. Subject has previously been enrolled and received a study platelet transfusion.
• \. Subject has known bleeding diathesis (hemophilia, Von Willebrand Disease, or others)
• \. At discretion of subject's physician, Sub-Investigator (SI), or Principle Investigator (PI).

Sponsors & Collaborators

• Moritz Stolla, MD: lead
• United States Department of Defense: collaborator

Study Sites (1)

Swedish Medical Center - Cherry Hill

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Blood Platelet Disorders; Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Intraoperative Complications

Study Officials

• Moritz Stolla, MD

  Bloodworks Northwest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Miles, M.S.

CONTACT

206-689-6285; jmiles@bloodworksnw.org

Pat Klotz, BSN

CONTACT

206-568-2238; pklotz@bloodworksnw.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Platelet Transfusion Research Laboratory (Stolla Lab); Associate Medical Direct, Transfusion Service Swedish Medical Center; Assistant Professor of Medicine, University of Washington

Model Details: Subjects will be assigned to 1 of 2 treatment groups.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: February 2, 2022
• Study Start: February 21, 2022
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)