← Back to Search

Platelet Transfusion

Cryopreserved Platelets for Cardiac Surgery (CRYPTICS Trial)

Phase 2 & 3
Recruiting
Led By Kenichi Tanaka, MD
Research Sponsored by Cellphire, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All re-operative cardiac procedures.
Any procedure that in the estimation of the surgical attending, has a high likelihood of receiving platelets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier
Awards & highlights

CRYPTICS Trial Summary

This trial is comparing two different types of platelets to see which one is better at controlling blood loss during surgery.

Who is the study for?
Adults at least 18 years old undergoing cardiopulmonary bypass surgery with a risk of post-surgical bleeding can join. They must understand and agree to the study's terms, use effective birth control if applicable, and be likely to need platelets during surgery. Those with coronary artery bypass alone, ventricular assist device implantation, certain health conditions or allergies cannot participate.Check my eligibility
What is being tested?
The trial is testing whether Cryopreserved Platelets are as good as or better than Liquid Stored Platelets for controlling blood loss in patients having heart surgery involving cardiopulmonary bypass. Participants will randomly receive one of the two platelet types.See study design
What are the potential side effects?
Potential side effects may include reactions related to transfusion such as fever, allergic reactions, immune system responses against the transfused platelets or infection transmission; however specific risks from cryopreserved platelets will be monitored.

CRYPTICS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had more than one heart surgery.
Select...
My surgery is likely to require a platelet transfusion.
Select...
I have had heart surgery involving valves or bypass.
Select...
I am having heart surgery and have a risk of bleeding afterwards.
Select...
I am 18 years old or older.

CRYPTICS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
Secondary outcome measures
Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours post time zero or when the chest tubes are removed.
Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Secondary Efficacy Endpoint assessed at the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
+4 more

CRYPTICS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cryopreserved plateletsExperimental Treatment1 Intervention
Cryopreserved platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal
Group II: Liquid stored plateletsActive Control1 Intervention
Liquid stored platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal

Find a Location

Who is running the clinical trial?

Cellphire, Inc.Lead Sponsor
4 Previous Clinical Trials
60 Total Patients Enrolled
Cellphire Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
100 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
244,959 Total Patients Enrolled

Media Library

Human platelets (Platelet Transfusion) Clinical Trial Eligibility Overview. Trial Name: NCT04709705 — Phase 2 & 3
Cardiac Surgery Research Study Groups: Cryopreserved platelets, Liquid stored platelets
Cardiac Surgery Clinical Trial 2023: Human platelets Highlights & Side Effects. Trial Name: NCT04709705 — Phase 2 & 3
Human platelets (Platelet Transfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04709705 — Phase 2 & 3
Cardiac Surgery Patient Testimony for trial: Trial Name: NCT04709705 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research still ongoing?

"Yes, this clinical trial is still recruiting patients. The latest update on the status of recruitment was posted on 11/3/2022, and the trial was originally advertised on 9/23/2021."

Answered by AI

Are there different facilities where I can participate in this research?

"There are 12 recruiting sites for this trial, but a few notable ones include University of Maryland Medical Center in Baltimore, George Washington University in Washington D.C., and Johns Hopkins University in Durham, North carolina."

Answered by AI

How many people fit the bill for this particular experiment?

"To conduct this research, we require 200 individuals who fit the pre-specified inclusion criteria. Those eligible can take part in the trial at locations such as University of Maryland Medical Center or George Washington University."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Iam interested and willing to help with this an other study's.
PatientReceived no prior treatments
~46 spots leftby Jan 2025