Clinical trial NCT04834414: CHIlled Platelet Study "CHIPS"
Official title: CHIlled Platelet Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Blood Loss
Keywords: platelets
cold-stored platelets
bleeding
hemostasis
complex cardiac surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Utah
name: University of Minnesota
name: Washington University School of Medicine
name: United States Department of Defense
name: University of Pittsburgh
First posted: 2021-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Adaptive Design
Primary purpose: TREATMENT

Brief summary: A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.


Eligibility criteria: Inclusion Criteria:

* Viable neonates ≥ 3 kg at time of enrollment (as defined in Section 4.1) OR age greater than 28 days and less than 85 years of age at time of consent; AND
* Planned complex cardiac surgery with planned use of cardiopulmonary bypass, with an expectation of bleeding requiring platelet transfusion.

Exclusion Criteria:

* Expected order for washed or volume reduced platelets
* Patient with known anti-platelet antibodies
* Platelet transfusion refractoriness due to anti-HLA antibodies
* Known or suspected pregnancy
* Previously randomized in this study
* Conscious objection or unwillingness to receive blood products
* Known IgA deficiency
* Known congenital platelet disorder
* Known congenital bleeding disorder
* Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
* Patients intended to receive whole blood either intra-operative or post-operative for bleeding
* Platelet transfusion (of any type) within 24 hours prior to the date of surgery
* Pre-operative thrombocytopenia, defined as platelet count \<75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery.

Primary outcomes:
measure: Hemostatic efficacy
timeFrame: 24 hours after first study platelet transfusion
Secondary outcomes:
measure: Chest tube output
timeFrame: 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)
Other outcomes:
measure: Blood product administration
timeFrame: 24 and 72 hours from start time of first study platelet transfusion
measure: Total Dose of individual hemostatic adjuncts
timeFrame: 24 and 72 hours from start time of first study platelet transfusion
measure: Mechanical ventilation
timeFrame: up to 28 days after first study platelet transfusion
measure: Length of stay
timeFrame: up to 28 days
measure: Relative change in hemostatic parameters
timeFrame: 6 and 24 hours after first study platelet transfusion
measure: Unplanned sternal closure delay
timeFrame: prior to ICU admission
measure: Re-exploration for bleeding
timeFrame: 24 hours first study platelet transfusion
measure: Unplanned extracorporeal support post operatively
timeFrame: within 48 hours of first study platelet transfusion
measure: Morbidities after ICU admission
timeFrame: within 7 days of first study platelet transfusion
measure: Measures of end organ injury
timeFrame: within 48 hours of first study platelet transfusion
measure: Transfusion associated adverse events
timeFrame: within 7 days of first study platelet transfusion
measure: Arterial thrombotic event
timeFrame: within 7 days of first study platelet transfusion
measure: Venous thrombotic event
timeFrame: within 7 days of first study platelet transfusion
measure: All cause mortality
timeFrame: up to 28 days
Locations:
city: Pheonix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tuscon
country: United States
facility: Banner University Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola Universtiy Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Children's Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Medical Center Clements
state: Texas
city: Houston
country: United States
facility: Baylor Texas Children's
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin- Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: University of Pittsburgh
name: Philip C Spinella, MD
role: STUDY_DIRECTOR
affiliation: University of Minnesota
name: Marie E Steiner, MD
role: STUDY_DIRECTOR
affiliation: University of Minnesota
name: Nicole D Zantek, MD
role: STUDY_DIRECTOR
References:
citation: Krachey E, Viele K, Spinella PC, Steiner ME, Zantek ND, Lewis RJ. The design of an adaptive clinical trial to evaluate the efficacy of platelets stored at low temperature in surgical patients. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S41-S46. doi: 10.1097/TA.0000000000001876.
citation: Strandenes G, Sivertsen J, Bjerkvig CK, Fosse TK, Cap AP, Del Junco DJ, Kristoffersen EK, Haaverstad R, Kvalheim V, Braathen H, Lunde THF, Hervig T, Hufthammer KO, Spinella PC, Apelseth TO. A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery. Anesthesiology. 2020 Dec 1;133(6):1173-1183. doi: 10.1097/ALN.0000000000003550.
citation: Zantek ND, Steiner ME, VanBuren JM, Lewis RJ, Berry NS, Viele K, Krachey E, Dean JM, Nelson S, Spinella PC. Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study. Clin Trials. 2023 Feb;20(1):36-46. doi: 10.1177/17407745221126423. Epub 2022 Dec 21.