CHIlled Platelet Study "CHIPS" (CHIPS)

CHIlled Platelet Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Blood Loss
• Intervention / Treatment: Biological: Room Temperature Platelets; Biological: Cold Stored Platelets

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
    • Tucson, Arizona, United States, 85713
      • Banner University Medical Center
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola Universtiy Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02910
      • Rhode Island Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Children's Medical Center
    • Dallas, Texas, United States, 75235
      • University of Texas Medical Center Clements
    • Houston, Texas, United States, 77030
      • Memorial Hermann Texas Medical Center
    • Houston, Texas, United States, 77030
      • Baylor Texas Children's
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin- Madison
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 84 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Room Temperature Platelets; Platelets stored at 20-24 degrees Celsius	Biological: Room Temperature Platelets; Platelets stored at 20-24 degrees Celsius
Experimental: Cold Stored Platelets; Platelets stored at 1-6 degree Celsius	Biological: Cold Stored Platelets; Platelets stored at 1-6 degree Celsius

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostatic efficacy	Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome.	24 hours after first study platelet transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest tube output	Assessed by volume	24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood product administration	The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood	24 and 72 hours from start time of first study platelet transfusion
Total Dose of individual hemostatic adjuncts	Antifibrinolytic and coagulation factor concentrates	24 and 72 hours from start time of first study platelet transfusion
Mechanical ventilation	Duration of mechanical ventilation days	up to 28 days after first study platelet transfusion
Length of stay	ICU and hospital length of stay	up to 28 days
Relative change in hemostatic parameters	CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG	6 and 24 hours after first study platelet transfusion
Unplanned sternal closure delay	Sternum left open after cardiac surgery	prior to ICU admission
Re-exploration for bleeding	Return to OR after ICU admission	24 hours first study platelet transfusion
Unplanned extracorporeal support post operatively	Placed on ECMO	within 48 hours of first study platelet transfusion
Morbidities after ICU admission	Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock	within 7 days of first study platelet transfusion
Measures of end organ injury	If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically.	within 48 hours of first study platelet transfusion
Transfusion associated adverse events	As per CDC guidelines	within 7 days of first study platelet transfusion
Arterial thrombotic event	Stroke, MI	within 7 days of first study platelet transfusion
Venous thrombotic event	Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram	within 7 days of first study platelet transfusion
All cause mortality	Death for any reason	up to 28 days

Collaborators and Investigators

• Sponsor: Philip Spinella
• Collaborators: Washington University School of Medicine; United States Department of Defense; University of Pittsburgh; University of Minnesota; University of Utah
• Investigators: Study Director: Philip C Spinella, MD, University of Pittsburgh; Study Director: Marie E Steiner, MD, University of Minnesota; Study Director: Nicole D Zantek, MD, University of Minnesota

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): March 25, 2025
• Study Completion (Actual): April 21, 2025

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: bleeding; platelets; hemostasis; cold-stored platelets; complex cardiac surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: ChiPS; W81XWH2090021 (Other Grant/Funding Number: DoD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No