CHIlled Platelet Study "CHIPS"

• Sponsor: Philip Spinella (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04834414
• Collaborator: University of Utah (Other), University of Minnesota (Other), Washington University School of Medicine (Other), United States Department of Defense (U.S. Fed)
• Enrollment: 1,000
• Locations: 14
• Arms: 2
• Anticipated Duration (Months): 29.3
• Patients Per Site: 71.4
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Blood Loss	Biological: Cold Stored Platelets; Biological: Room Temperature Platelets	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Adaptive DesignAdaptive Design
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Partial Blind
• Primary Purpose: Treatment
• Official Title: CHIlled Platelet Study
• Actual Study Start Date: Oct 21, 2021
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Room Temperature Platelets Platelets stored at 20-24 degrees Celsius	Biological: Room Temperature Platelets; Platelets stored at 20-24 degrees Celsius
Experimental: Cold Stored Platelets Platelets stored at 1-6 degree Celsius	Biological: Cold Stored Platelets; Platelets stored at 1-6 degree Celsius

Outcome Measures

Primary Outcome Measures

1. Hemostatic efficacy [24 hours after first study platelet transfusion]

   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

1. Chest tube output [24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)]

   Assessed by volume

Other Outcome Measures

1. Blood product administration [24 and 72 hours from start time of first study platelet transfusion]

   The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood

2. Total Dose of individual hemostatic adjuncts [24 and 72 hours from start time of first study platelet transfusion]

   Antifibrinolytic and coagulation factor concentrates

3. Mechanical ventilation [up to 28 days after first study platelet transfusion]

   Duration of mechanical ventilation days

4. Length of stay [up to 28 days]

   ICU and hospital length of stay

5. Relative change in hemostatic parameters [6 and 24 hours after first study platelet transfusion]

   CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG

6. Unplanned sternal closure delay [prior to ICU admission]

   Sternum left open after cardiac surgery

7. Re-exploration for bleeding [24 hours first study platelet transfusion]

   Return to OR after ICU admission

8. Unplanned extracorporeal support post operatively [within 48 hours of first study platelet transfusion]

   Placed on ECMO

9. Morbidities after ICU admission [within 7 days of first study platelet transfusion]

   Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock

10. Measures of end organ injury [within 48 hours of first study platelet transfusion]

    If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically.

11. Transfusion associated adverse events [within 7 days of first study platelet transfusion]

    As per CDC guidelines

12. Arterial thrombotic event [within 7 days of first study platelet transfusion]

    Stroke, MI

13. Venous thrombotic event [within 7 days of first study platelet transfusion]

    Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram

14. All cause mortality [up to 28 days]

    Death for any reason

Eligibility Criteria

Criteria

• Ages Eligible for Study: 29 Days to 84 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
2	University of Florida	Gainesville	Florida	United States	32608
3	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
4	John Hopkins	Baltimore	Maryland	United States	21287
5	Mayo Clnic	Rochester	Minnesota	United States	55905
6	Wake Forest	Winston-Salem	North Carolina	United States	27157
7	Cincinnati Children's Hospital	Cincinnati	Ohio	United States	45229
8	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
9	University of Pittsburgh Pennsylvania	Pitts	Pennsylvania	United States	15232
10	Rhode Island Hospital	Providence	Rhode Island	United States	02910
11	University of Texas Children's Medical Center	Dallas	Texas	United States	75235
12	University of Texas Medical Center Clements	Dallas	Texas	United States	75235
13	Baylor Texas Children's	Houston	Texas	United States	77030
14	University of Wisconsin- Madison	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Philip Spinella
• University of Utah
• University of Minnesota
• Washington University School of Medicine
• United States Department of Defense

Investigators

• Principal Investigator: Philip C Spinella, MD, University of Pittsburgh
• Principal Investigator: Marie E Steiner, MD, University of Minnesota
• Principal Investigator: Nicole D Zantek, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Philip Spinella, Professor- Surgery and Critical Care Medicine, Co- Director- Trauma and Transfusion Medicine Research Center, Associate Medical Director- Center for Military Medicine Research, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04834414
• Other Study ID Numbers: CHIPS; W81XWH2090021
• First Posted: Apr 8, 2021
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Philip Spinella, Professor- Surgery and Critical Care Medicine, Co- Director- Trauma and Transfusion Medicine Research Center, Associate Medical Director- Center for Military Medicine Research, University of Pittsburgh: platelets; cold-stored platelets; bleeding; hemostasis; complex cardiac surgery
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Aug 25, 2022