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CHIlled Platelet Study "CHIPS"

P

Philip Spinella

Status and phase

Enrolling
Phase 3

Conditions

Acute Blood Loss

Treatments

Biological: Cold Stored Platelets
Biological: Room Temperature Platelets

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04834414
W81XWH2090021 (Other Grant/Funding Number)
CHIPS

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

Under 84 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

1,000 participants in 2 patient groups

Room Temperature Platelets
Active Comparator group
Description:
Platelets stored at 20-24 degrees Celsius
Treatment:
Biological: Room Temperature Platelets
Cold Stored Platelets
Experimental group
Description:
Platelets stored at 1-6 degree Celsius
Treatment:
Biological: Cold Stored Platelets

Trial contacts and locations

27

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Central trial contact

Meghan Huff, BSN; Christina Daniel, BSN

Data sourced from clinicaltrials.gov

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