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CHIlled Platelet Study "CHIPS"

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age greater than 28 days and less than 85 years.
  • Planned complex cardiac surgery with planned use of cardiopulmonary bypass.

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 receiving study platelets.
  • Pre-operative thrombocytopenia.

Eligibility last updated 11/2/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Allan Klompas, M.B., B.Ch., B.A.O.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Beth Montonye R.N.

(507) 538-4344

Montonye.Beth@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bradford Smith, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Kayla Haeger R.N.

(480) 342-5075

Haeger.Kayla@mayo.edu

More information

Publications

  • Platelet transfusion is a potentially life-saving therapy for actively bleeding patients, ranging from those undergoing planned surgical procedures to those suffering unexpected traumatic injuries. Platelets are currently stored at room temperature (20°C-24°C) with a maximum storage duration of 7 days after donation. The CHIlled Platelet Study trial will compare the efficacy and safety of standard room temperature-stored platelets with platelets that are cold-stored (1°C-6°C), that is, chilled, with a maximum of storage up to 21 days in adult and pediatric patients undergoing complex cardiac surgical procedures. Read More on PubMed
  • This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials. Read More on PubMed
  • Storage of platelets at 4°C compared with 22°C may increase both hemostatic activity and storage duration; however, the maximum duration of cold storage is unknown. We report the design of an innovative, prospective, randomized, Bayesian adaptive, "duration finding" clinical trial to evaluate the efficacy and maximum duration of storage of platelets at 4°C. Read More on PubMed

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