Acute Blood LossPhase 3CHIPSNCT04834414
CHIlled Platelet Study "CHIPS"
A Phase 3 study testing Cold Stored Platelets and Room Temperature Platelets in people with Acute Blood Loss, run by Philip Spinella at 27 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 84 years
- Conditions the study is for
- Acute Blood Loss
- What is being tested?
- Cold Stored Platelets and Room Temperature Platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 21 Oct 2021to 21 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 84 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States25 sites
University of Michigan
Ann Arbor, Michigan, 48109
John Hopkins
Baltimore, Maryland, 21287
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
University of Texas Children's Medical Center
Dallas, Texas, 75235
University of Texas Medical Center Clements
Dallas, Texas, 75235
University of Florida
Gainesville, Florida, 32608
Baylor Texas Children's
Houston, Texas, 77030
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66103
University of Kentucky
Lexington, Kentucky, 40536
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
University of Wisconsin- Madison
Madison, Wisconsin, 53792
Loyola Universtiy Medical Center
Maywood, Illinois, 60153
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Mayo Clinic Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02910
Mayo Clinic
Rochester, Minnesota, 55905
Banner University Medical Center
Tucson, Arizona, 85713
Wake Forest
Winston-Salem, North Carolina, 27157
Australia2 sites
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
About this study
Official title: CHIlled Platelet 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. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.
- Conditions
- Acute Blood Loss
- Being tested
- Cold Stored Platelets, Room Temperature Platelets
- Keywords
- platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Stored PlateletsBiological
Platelets stored at 1-6 degree Celsius
Room Temperature PlateletsBiological
Platelets stored at 20-24 degrees Celsius
| Study group | Role | What they receive |
|---|---|---|
| Room Temperature Platelets | Active comparator | Platelets stored at 20-24 degrees Celsius Receives: Biological: Room Temperature Platelets |
| Cold Stored Platelets | Experimental | Platelets stored at 1-6 degree Celsius Receives: Biological: Cold Stored Platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after first study platelet transfusion
Secondary outcomes (1)
Chest tube output
Assessed by volume
Measured: 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 Oct 2021
- Primary completion25 Mar 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Adaptive Design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Spinella
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, University of Minnesota, Washington University School of Medicine, United States Department of Defense, University of Pittsburgh
- Responsible party
- Sponsor-investigator, Philip Spinella, University of Pittsburgh
- Investigators
- Philip C Spinella, MD, Study director, University of PittsburghMarie E Steiner, MD, Study director, University of MinnesotaNicole D Zantek, MD, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834414
- Sponsor's protocol ID
- CHIPS
- Other IDs
- W81XWH2090021
- Acronym
- CHIPS
- Status last verified
- Jul 2025
- First submitted
- 31 Mar 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29521797Strandenes 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.
PubMed 32902572Zantek 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.
PubMed 36541257Spinella PC, Zantek ND, VanBuren JM, Nicolson SC, Khanna AK, Klompas AM, Boisen ML, Williams TM, Monteleone M, Bashir DA, Pavey W, Smith BB, Ahmed MI, Niebler RA, Jeng E, Flynn BC, Joshi RV, Preuss JF, Goswami D, Yamada C, Lewis C, Cohn CS, Tint H, Kwak J, Sodha N, Simon ER, Van PY, Greilich PE, Booth FVM, Carter CP, Keegan A, Cap AP, Matuk J, McGlothlin A, Berry NS, Lewis RJ, Steiner ME; CHIPS Investigator Group. Cold and Room-Temperature Platelets in Cardiac Surgery: The CHIPS Randomized Clinical Trial. JAMA. 2026 Aug 17. doi: 10.1001/jama.2026.13328. Online ahead of print.
PubMed 42606886Lewis AR, Peffley N, Klompas AM, Ashrani AA. Role of individual factor X concentrate pharmacokinetic studies in perioperative management of AL amyloidosis-associated acquired factor X deficiency. Transfusion. 2023 Sep;63(9):1773-1777. doi: 10.1111/trf.17477. Epub 2023 Jul 10.
PubMed 37427705Klompas AM, Stubbs J. Massive transfusion protocol: What's in a name? Transfusion. 2023 Apr;63(4):896-897. doi: 10.1111/trf.17297. No abstract available.
PubMed 37038736
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHIlled Platelet Study
- ClinicalTrials.gov ID
- NCT04834414
- Acronym / sponsor ID
- CHIPS / CHIPS
- Conditions
- Acute Blood Loss
- Keywords
- platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Philip SpinellaUniversity, hospital or other
- Collaborators
- University of Utah, University of Minnesota, Washington University School of Medicine, United States Department of Defense, University of Pittsburgh
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Adaptive Design
| Arm | Type | Receives |
|---|---|---|
| Room Temperature Platelets | Active comparator | Biological: Room Temperature PlateletsPlatelets stored at 20-24 degrees Celsius |
| Cold Stored Platelets | Experimental | Biological: Cold Stored PlateletsPlatelets stored at 1-6 degree Celsius |
Who may qualify
- Ages
- 0 days to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Stored PlateletsPlatelets stored at 1-6 degree Celsius | Biological | Cold Stored Platelets |
| Room Temperature PlateletsPlatelets stored at 20-24 degrees Celsius | Biological | Room Temperature Platelets |
Primary outcome
Hemostatic efficacy
Time frame: 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.
1 secondary outcome
Chest tube output
Time frame: 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 29521797Krachey 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.
- Background: PubMed 32902572Strandenes 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.
- Background: PubMed 36541257Zantek 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.
- Derived from this study: PubMed 42606886Spinella PC, Zantek ND, VanBuren JM, Nicolson SC, Khanna AK, Klompas AM, Boisen ML, Williams TM, Monteleone M, Bashir DA, Pavey W, Smith BB, Ahmed MI, Niebler RA, Jeng E, Flynn BC, Joshi RV, Preuss JF, Goswami D, Yamada C, Lewis C, Cohn CS, Tint H, Kwak J, Sodha N, Simon ER, Van PY, Greilich PE, Booth FVM, Carter CP, Keegan A, Cap AP, Matuk J, McGlothlin A, Berry NS, Lewis RJ, Steiner ME; CHIPS Investigator Group. Cold and Room-Temperature Platelets in Cardiac Surgery: The CHIPS Randomized Clinical Trial. JAMA. 2026 Aug 17. doi: 10.1001/jama.2026.13328. Online ahead of print.
- Derived from this study: PubMed 37427705Lewis AR, Peffley N, Klompas AM, Ashrani AA. Role of individual factor X concentrate pharmacokinetic studies in perioperative management of AL amyloidosis-associated acquired factor X deficiency. Transfusion. 2023 Sep;63(9):1773-1777. doi: 10.1111/trf.17477. Epub 2023 Jul 10.
- Derived from this study: PubMed 37038736Klompas AM, Stubbs J. Massive transfusion protocol: What's in a name? Transfusion. 2023 Apr;63(4):896-897. doi: 10.1111/trf.17297. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip C Spinella, MD study director
University of Pittsburgh
Marie E Steiner, MD study director
University of Minnesota
Nicole D Zantek, MD study director
University of Minnesota
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cold Stored Platelets and Room Temperature Platelets in people with Acute Blood Loss, run by Philip Spinella at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic efficacy (time frame: 24 hours after first study platelet transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834414, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.