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CHIlled Platelet Study "CHIPS" (CHIPS)

Primary Purpose

Acute Blood Loss

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cold Stored Platelets
Room Temperature Platelets
Sponsored by
Philip Spinella
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Blood Loss focused on measuring platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery

Eligibility Criteria

29 Days - 84 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Mayo Clinic ArizonaRecruiting
  • Banner University Medical CenterRecruiting
  • Ronald Reagan UCLA Medical CenterRecruiting
  • University of FloridaRecruiting
  • Northwestern Memorial HospitalRecruiting
  • Loyola Universtiy Medical CenterRecruiting
  • University of Kansas Medical CenterRecruiting
  • John HopkinsRecruiting
  • University of MichiganRecruiting
  • University of MinnesotaRecruiting
  • Mayo ClinicRecruiting
  • Wake ForestRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Rhode Island HospitalRecruiting
  • University of Texas Children's Medical CenterRecruiting
  • University of Texas Medical Center ClementsRecruiting
  • Baylor Texas Children'sRecruiting
  • Memorial Hermann Texas Medical Center
  • University of Wisconsin- MadisonRecruiting
  • Aurora St. Luke's Medical CenterRecruiting
  • Children's Hospital of WisconsinRecruiting
  • Fiona Stanley HospitalRecruiting
  • Sir Charles Gairdner Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Room Temperature Platelets

Cold Stored Platelets

Arm Description

Platelets stored at 20-24 degrees Celsius

Platelets stored at 1-6 degree Celsius

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Chest tube output
Assessed by volume

Full Information

First Posted
March 31, 2021
Last Updated
October 11, 2023
Sponsor
Philip Spinella
Collaborators
University of Utah, University of Minnesota, Washington University School of Medicine, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04834414
Brief Title
CHIlled Platelet Study "CHIPS"
Acronym
CHIPS
Official Title
CHIlled Platelet Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philip Spinella
Collaborators
University of Utah, University of Minnesota, Washington University School of Medicine, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Blood Loss
Keywords
platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
Adaptive Design
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Partial Blind
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Room Temperature Platelets
Arm Type
Active Comparator
Arm Description
Platelets stored at 20-24 degrees Celsius
Arm Title
Cold Stored Platelets
Arm Type
Experimental
Arm Description
Platelets stored at 1-6 degree Celsius
Intervention Type
Biological
Intervention Name(s)
Cold Stored Platelets
Intervention Description
Platelets stored at 1-6 degree Celsius
Intervention Type
Biological
Intervention Name(s)
Room Temperature Platelets
Intervention Description
Platelets stored at 20-24 degrees Celsius
Primary Outcome Measure Information:
Title
Hemostatic efficacy
Description
Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome.
Time Frame
24 hours after first study platelet transfusion
Secondary Outcome Measure Information:
Title
Chest tube output
Description
Assessed by volume
Time Frame
24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)
Other Pre-specified Outcome Measures:
Title
Blood product administration
Description
The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood
Time Frame
24 and 72 hours from start time of first study platelet transfusion
Title
Total Dose of individual hemostatic adjuncts
Description
Antifibrinolytic and coagulation factor concentrates
Time Frame
24 and 72 hours from start time of first study platelet transfusion
Title
Mechanical ventilation
Description
Duration of mechanical ventilation days
Time Frame
up to 28 days after first study platelet transfusion
Title
Length of stay
Description
ICU and hospital length of stay
Time Frame
up to 28 days
Title
Relative change in hemostatic parameters
Description
CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG
Time Frame
6 and 24 hours after first study platelet transfusion
Title
Unplanned sternal closure delay
Description
Sternum left open after cardiac surgery
Time Frame
prior to ICU admission
Title
Re-exploration for bleeding
Description
Return to OR after ICU admission
Time Frame
24 hours first study platelet transfusion
Title
Unplanned extracorporeal support post operatively
Description
Placed on ECMO
Time Frame
within 48 hours of first study platelet transfusion
Title
Morbidities after ICU admission
Description
Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock
Time Frame
within 7 days of first study platelet transfusion
Title
Measures of end organ injury
Description
If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically.
Time Frame
within 48 hours of first study platelet transfusion
Title
Transfusion associated adverse events
Description
As per CDC guidelines
Time Frame
within 7 days of first study platelet transfusion
Title
Arterial thrombotic event
Description
Stroke, MI
Time Frame
within 7 days of first study platelet transfusion
Title
Venous thrombotic event
Description
Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram
Time Frame
within 7 days of first study platelet transfusion
Title
All cause mortality
Description
Death for any reason
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Huff, BSN
Phone
314-362-1319
Email
meghanhuff@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Daniel, BSN
Email
christina.daniel@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip C Spinella, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie E Steiner, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole D Zantek, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Haeger
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Carlson
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Scovotti
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaafira Haque
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Fitzgerald
Facility Name
Loyola Universtiy Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Shoenecker
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Kirchhoff
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Mennie
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wajid Kahn
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Therese Chlebeck
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Montonye
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynne Harris
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaynee Bartsch
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitri Buckallew
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Hu
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisha Maslanka
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Cheves
Facility Name
University of Texas Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delaney Evans
Facility Name
University of Texas Medical Center Clements
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Matlock
Facility Name
Baylor Texas Children's
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Malivers
Facility Name
Memorial Hermann Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Ali
Facility Name
University of Wisconsin- Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schiltz
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phyllis Runningen
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Cole
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastazia Keegan
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastazia Keegan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29521797
Citation
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.
Results Reference
background
PubMed Identifier
32902572
Citation
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.
Results Reference
background
PubMed Identifier
36541257
Citation
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.
Results Reference
background

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CHIlled Platelet Study "CHIPS"

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