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Frozen platelets could be just as good as fresh ones for heart surgery bleeding

NCT ID NCT04709705

Disease control Sponsor: Cellphire Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether frozen platelets work as well as standard liquid platelets to control bleeding in 161 adults having heart surgery with a heart-lung machine. The goal was to see if the frozen version is a safe and effective option. The trial compared the amount of blood lost through chest drains after surgery between the two groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

161 people

The number who actually took part.

Started

Oct 2021

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, at least 18 years of age 2. Undergoing CPB surgery with at least one risk factor for post-surgical bleeding including: 1. All re-operative cardiac procedures. 2. Expected bypass \> 120 minutes. 3. Any combined cardiac surgery procedures (e.g. multiple valve, valve/CABG). 4. Any procedure that in the estimation of the surgical attending, has a high likelihood of receiving platelets 3. Ability to comprehend and willingness to sign informed consent. 4. If female of childbearing potential, have a negative pregnancy test on the day of the surgery and prior to the surgery agrees to use a method of highly effective birth control from the time of consent through the end of the safety follow-up period (Day 6 or discharge from hospital, whichever is earlier). Note: women must have been surgically sterilized \[bilateral tubal ligation, bilateral oophorectomy, total hysterectomy) or postmenopausal (≥50 years of age and continuous amenorrhea for 24 months) to be considered non-childbearing potential. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Undergoing any of the following surgical procedures: 1. Coronary artery bypass surgery alone 2. Implantation of ventricular assist device 3. Thoracoabdominal aortic aneurysm repair 2. Known or suspected pregnancy or breastfeeding 3. History of any major unprovoked thrombotic events 4. History of heparin-inducted thrombocytopenia 5. Active infection treated with antibiotics 6. Refuse transfusion of blood products for religious or other reasons 7. Previous enrollment in this study 8. Immune thrombocytopenic purpura 9. Known allergy to DMSO 10. In the judgement of the investigator, is not a good candidate for the study

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgery

Contacts and locations

Locations

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Inova Cardiac Vascular

    Falls Church, Virginia, 22042, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • OU Medical Center

    Oklahoma City, Oklahoma, 73104, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • The Ohio State Univ. Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson Univ. Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UF Health

    Gainesville, Florida, 32608, United States

  • University of Alabama

    Birmingham, Alabama, 35205, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

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