COMPLETED

DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)

Quick Facts

Study Start:2021-10-27

Study Completion:2025-05-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04709705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Locations (Sites)

University of Alabama

Birmingham, Alabama, 35205

United States

University of Colorado

Aurora, Colorado, 80045

United States

George Washington University

Washington D.C., District of Columbia, 20037

United States

UF Health

Gainesville, Florida, 32608

United States

Maine Medical Center

Portland, Maine, 04102

United States

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Johns Hopkins University

Baltimore, Maryland, 21218

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

Duke University Hospital

Durham, North Carolina, 27710

United States

The Ohio State Univ. Wexner Medical Center

Columbus, Ohio, 43210

United States

OU Medical Center

Oklahoma City, Oklahoma, 73104

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Abington Memorial Hospital

Abington, Pennsylvania, 19001

United States

Thomas Jefferson Univ. Hospital

Philadelphia, Pennsylvania, 19107

United States

University of Virginia Medical Center

Charlottesville, Virginia, 22908

United States

Inova Cardiac Vascular

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: Cellphire Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-27

Study Completion Date2025-05-08

Study Record Updates

Study Start Date2021-10-27

Study Completion Date2025-05-08

Terms related to this study

Keywords Provided by Researchers

Cryopreserved Platelets

Additional Relevant MeSH Terms

Cardiac Surgery