Cardiac SurgeryPhase 2/3CRYPTICSNCT04709705
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
A Phase 2/3 study testing Human platelets in people with Cardiac Surgery, run by Cellphire Therapeutics, Inc. at 16 sites in United States.
Trial summary
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Human platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 16 sitesUnited States
- Study dates
- 27 Oct 2021to 8 May 2025
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age
- Undergoing CPB surgery with at least one risk factor for post-surgical bleeding including:
- All re-operative cardiac procedures.
- Expected bypass > 120 minutes.
- Any combined cardiac surgery procedures (e.g. multiple valve, valve/CABG).
- Any procedure that in the estimation of the surgical attending, has a high likelihood of receiving platelets
- Ability to comprehend and willingness to sign informed consent.
- 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.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Undergoing any of the following surgical procedures:
- Coronary artery bypass surgery alone
- Implantation of ventricular assist device
- Thoracoabdominal aortic aneurysm repair
- Known or suspected pregnancy or breastfeeding
Show all 14Show fewer
- History of any major unprovoked thrombotic events
- History of heparin-inducted thrombocytopenia
- Active infection treated with antibiotics
- Refuse transfusion of blood products for religious or other reasons
- Previous enrollment in this study
- Immune thrombocytopenic purpura
- Known allergy to DMSO
- In the judgement of the investigator, is not a good candidate for the study
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
University of Colorado
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21218
University of Alabama
Birmingham, Alabama, 35205
University of Virginia Medical Center
Charlottesville, Virginia, 22908
The Ohio State Univ. Wexner Medical Center
Columbus, Ohio, 43210
Duke University Hospital
Durham, North Carolina, 27710
Inova Cardiac Vascular
Falls Church, Virginia, 22042
UF Health
Gainesville, Florida, 32608
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
OU Medical Center
Oklahoma City, Oklahoma, 73104
Thomas Jefferson Univ. Hospital
Philadelphia, Pennsylvania, 19107
Maine Medical Center
Portland, Maine, 04102
Oregon Health and Science University
Portland, Oregon, 97239
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery.
Read the detailed description
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Patients planning to undergo Cardiopulmonary Bypass Surgery with risk factors for significant bleeding post-surgery will be approached. Subjects will be randomized in a 1:1 ratio to receive either Cryopreserved Platelets or Liquid Stored Platelets. Eligible subjects will undergo Cardiopulmonary Bypass Surgery and at the completion of bypass and heparin reversal subjects will likely be assessed for eligibility before coming off bypass. Study platelets will be given either intraoperatively after heparin reversal and return of active clotting time (ACT) to < 140 sec or post operatively (after chest closure).
A single unblinded interim analysis on the primary efficacy endpoint will be performed for this study after 75% of the planned number of mITT subjects are treated (i.e., after 150 mITT subjects are treated, irrespective of the number of subjects in each treatment group).
- Conditions
- Cardiac Surgery
- Being tested
- Human platelets
- Keywords
- Cryopreserved Platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human plateletsBiological
Platelets given to control bleeding
| Study group | Role | What they receive |
|---|---|---|
| Cryopreserved platelets | Experimental | Cryopreserved platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal Receives: Biological: Human platelets |
| Liquid stored platelets | Active comparator | Liquid stored platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal Receives: Biological: Human platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
Total volume of chest tube drainage assessed by measurement of the volume of blood collected from the mediastinal and pleural drains from "time zero", the time of 1) chest closure or equivalent, 2) chest tubes or equivalent are attached to a graduated post drainage system, and 3) with suction (defined as time zero for analytical purposes) determined in mL/kg every hour during the first 12 hours and at 6-hour intervals thereafter, for up to 24 hours or chest tube removal (whichever is earlier).
Measured: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier
Secondary outcomes (7)
Secondary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
The primary endpoint given in mL/kg
Measured: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier
Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours post time zero or when the chest tubes are removed.
Chest tube drainage volume (mL) collected at 6 hours intervals through 24 hours post time zero or tube removal, whichever is earlier.
Measured: 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier.
Secondary Efficacy Endpoint at 6 hours intervals through 24 hours post time zero or when chest tubes are removed
Drainage rate (mL/hr) collected at 6 hours intervals through 24 hours post time zero or when chest tube are removed, whichever is earlier.
Measured: 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier
Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Total units by type of other post-operative blood products (pRBC, non-study platelets, CRYO, plasma, clotting factor concentrates) infused after the end of the first study platelet transfusion until end of the efficacy follow-up period
Measured: Infused after the end of the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Secondary Efficacy Endpoint assessed within 24 hour post heparin reversal (Efficacy follow-up period)
Incidence of surgical re-exploration and incidence of verified surgical or other causes for bleeding within the 24 hour period after heparin reversal
Measured: Within the 24 hour period after heparin reversal
Secondary Efficacy Endpoint assessed from first protamine administration to the time of first suture for incision closure on Day 1 (Day of Surgery)
Time to hemostasis (defined as the time from first protamine administration to the time when the surgeon initiates the first suture for incision closure)
Measured: Time from first protamine administration to the time when the surgeon initiates the first suture for incision closure, Day 1 (Day of operation)
Secondary Efficacy Endpoint assessed at the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Treatment failure (defined as requiring more than three units of study treatment (CPP or LSP))
Measured: Time of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start27 Oct 2021
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel group, active comparator-controlled trial to evaluate the noninferiority or superiority of CPP with LSP in controlling blood loss in patients undergoing CPB surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellphire Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709705
- Sponsor's protocol ID
- S-16-15
- Acronym
- CRYPTICS
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)
- ClinicalTrials.gov ID
- NCT04709705
- Acronym / sponsor ID
- CRYPTICS / S-16-15
- Conditions
- Cardiac Surgery
- Keywords
- Cryopreserved Platelets
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Cellphire Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 14 Jan 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 randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery.
Detailed description
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Patients planning to undergo Cardiopulmonary Bypass Surgery with risk factors for significant bleeding post-surgery will be approached. Subjects will be randomized in a 1:1 ratio to receive either Cryopreserved Platelets or Liquid Stored Platelets. Eligible subjects will undergo Cardiopulmonary Bypass Surgery and at the completion of bypass and heparin reversal subjects will likely be assessed for eligibility before coming off bypass. Study platelets will be given either intraoperatively after heparin reversal and return of active clotting time (ACT) to < 140 sec or post operatively (after chest closure).
A single unblinded interim analysis on the primary efficacy endpoint will be performed for this study after 75% of the planned number of mITT subjects are treated (i.e., after 150 mITT subjects are treated, irrespective of the number of subjects in each treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel group, active comparator-controlled trial to evaluate the noninferiority or superiority of CPP with LSP in controlling blood loss in patients undergoing CPB surgery.
| Arm | Type | Receives |
|---|---|---|
| Cryopreserved platelets | Experimental | Biological: Human plateletsCryopreserved platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal |
| Liquid stored platelets | Active comparator | Biological: Human plateletsLiquid stored platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, at least 18 years of age
- Undergoing CPB surgery with at least one risk factor for post-surgical bleeding including:
- Ability to comprehend and willingness to sign informed consent.
- 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.
Key exclusion criteria (14 listed)
- Undergoing any of the following surgical procedures:
- Known or suspected pregnancy or breastfeeding
- History of any major unprovoked thrombotic events
- History of heparin-inducted thrombocytopenia
- Active infection treated with antibiotics
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 |
|---|---|---|
| Human plateletsPlatelets given to control bleeding | Biological | Cryopreserved platelets, Liquid stored platelets |
Primary outcome
Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
Time frame: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier
Total volume of chest tube drainage assessed by measurement of the volume of blood collected from the mediastinal and pleural drains from "time zero", the time of 1) chest closure or equivalent, 2) chest tubes or equivalent are attached to a graduated post drainage system, and 3) with suction (defined as time zero for analytical purposes) determined in mL/kg every hour during the first 12 hours and at 6-hour intervals thereafter, for up to 24 hours or chest tube removal (whichever is earlier).
7 secondary outcomes
Secondary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
Time frame: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier
Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours post time zero or when the chest tubes are removed.
Time frame: 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier.
Secondary Efficacy Endpoint at 6 hours intervals through 24 hours post time zero or when chest tubes are removed
Time frame: 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier
Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Time frame: Infused after the end of the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Secondary Efficacy Endpoint assessed within 24 hour post heparin reversal (Efficacy follow-up period)
Time frame: Within the 24 hour period after heparin reversal
Secondary Efficacy Endpoint assessed from first protamine administration to the time of first suture for incision closure on Day 1 (Day of Surgery)
Time frame: Time from first protamine administration to the time when the surgeon initiates the first suture for incision closure, Day 1 (Day of operation)
Secondary Efficacy Endpoint assessed at the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Time frame: Time of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
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 1 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Human platelets in people with Cardiac Surgery, run by Cellphire Therapeutics, Inc. at 16 sites in United States.
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 8 inclusion and 14 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero. (time frame: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.