CHIlled Platelet Study "CHIPS"

NCT04834414 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: CHIPSW81XWH2090021
• Study Type: interventional
• Target: 1,000
• Locations: 2 countries
• Sites: 27

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.

Conditions

Acute Blood Loss

Keywords

platelets; cold-stored platelets; bleeding; hemostasis; complex cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Chest tube output

  24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)

Other Outcomes (14)

• Blood product administration

  24 and 72 hours from start time of first study platelet transfusion

• Total Dose of individual hemostatic adjuncts

  24 and 72 hours from start time of first study platelet transfusion

• Mechanical ventilation

  up to 28 days after first study platelet transfusion

Study Arms (2)

Room Temperature Platelets

ACTIVE COMPARATOR

Platelets stored at 20-24 degrees Celsius

Biological: Room Temperature Platelets

Cold Stored Platelets

EXPERIMENTAL

Platelets stored at 1-6 degree Celsius

Biological: Cold Stored Platelets

Interventions

Cold Stored Platelets BIOLOGICAL

Platelets stored at 1-6 degree Celsius

Cold Stored Platelets

Room Temperature Platelets BIOLOGICAL

Platelets stored at 20-24 degrees Celsius

Room Temperature Platelets

Eligibility Criteria

• Age: 0 Days - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Spinella: lead
• University of Utah: collaborator
• University of Minnesota: collaborator
• Washington University School of Medicine: collaborator
• United States Department of Defense: collaborator
• University of Pittsburgh: collaborator

Study Sites (27)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Banner University Medical Center

Tucson, Arizona, 85713, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Loyola Universtiy Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

John Hopkins

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02910, United States

Location

University of Texas Children's Medical Center

Dallas, Texas, 75235, United States

Location

University of Texas Medical Center Clements

Dallas, Texas, 75235, United States

Location

Baylor Texas Children's

Houston, Texas, 77030, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

University of Wisconsin- Madison

Madison, Wisconsin, 53792, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (5)

• 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.

  PMID: 29521797 BACKGROUND

• 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.

  PMID: 32902572 BACKGROUND

• 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.

  PMID: 36541257 BACKGROUND

• Lewis AR, Peffley N, Klompas AM, Ashrani AA. Role of individual factor X concentrate pharmacokinetic studies in perioperative management of AL amyloidosis-associated acquired factor X deficiency. Transfusion. 2023 Sep;63(9):1773-1777. doi: 10.1111/trf.17477. Epub 2023 Jul 10.

  PMID: 37427705 DERIVED

• Klompas AM, Stubbs J. Massive transfusion protocol: What's in a name? Transfusion. 2023 Apr;63(4):896-897. doi: 10.1111/trf.17297. No abstract available.

  PMID: 37038736 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Partial Blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor- Surgery and Critical Care Medicine, Co- Director- Trauma and Transfusion Medicine Research Center, Associate Medical Director- Center for Military Medicine Research

Model Details: Adaptive Design

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: October 21, 2021
• Primary Completion: March 25, 2025
• Study Completion: April 21, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (25); AU (2)