Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04834414




Registration number
NCT04834414
Ethics application status
Date submitted
31/03/2021
Date registered
8/04/2021
Date last updated
29/04/2024

Titles & IDs
Public title
CHIlled Platelet Study "CHIPS"
Scientific title
CHIlled Platelet Study
Secondary ID [1] 0 0
W81XWH2090021
Secondary ID [2] 0 0
CHIPS
Universal Trial Number (UTN)
Trial acronym
CHIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Blood Loss 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Cold Stored Platelets
Other interventions - Room Temperature Platelets

Active Comparator: Room Temperature Platelets - Platelets stored at 20-24 degrees Celsius

Experimental: Cold Stored Platelets - Platelets stored at 1-6 degree Celsius


Other interventions: Cold Stored Platelets
Platelets stored at 1-6 degree Celsius

Other interventions: Room Temperature Platelets
Platelets stored at 20-24 degrees Celsius
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemostatic efficacy
Timepoint [1] 0 0
24 hours after first study platelet transfusion
Secondary outcome [1] 0 0
Chest tube output
Timepoint [1] 0 0
24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)

Eligibility
Key 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.
Minimum age
0 Days
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6150 - Murdoch
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
Philip Spinella
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Utah
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Minnesota
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Washington University School of Medicine
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
United States Department of Defense
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Pittsburgh
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04834414
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Philip C Spinella, MD
Address 0 0
University of Pittsburgh
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Meghan Huff, BSN
Address 0 0
Country 0 0
Phone 0 0
314-362-1319
Fax 0 0
Email 0 0
meghanhuff@wustl.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04834414