NCT02485366 is a Phase 4 clinical trial of Rejuvesol in Heart Defects, Congenital, sponsored by Duke University.

Who is sponsoring NCT02485366?

NCT02485366 is sponsored by Duke University.

What drugs are being tested in NCT02485366?

Interventions in NCT02485366: Rejuvesol, Cardiac surgery.

What condition does NCT02485366 study?

NCT02485366 studies Heart Defects, Congenital.

Is NCT02485366 still recruiting?

NCT02485366 is currently withdrawn. Last updated 23 April 2020.

Last reviewed 2020-04-23 · How we verify

NCT02485366

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Withdrawn Phase 4 Last updated 23 April 2020

What this trial tests

Phase 4 trial testing Rejuvesol in Heart Defects, Congenital. Withdrawn.

Timeline

1 June 2020

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	Duke University
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Start date	1 June 2020
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	1 location across United States

Drugs / interventions tested

Rejuvesol — full drug profile →
Cardiac surgery

Conditions studied

Heart Defects, Congenital — all drugs for Heart Defects, Congenital →

Sponsor

Duke University

Who can join

Under 18, any sex, with Heart Defects, Congenital. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
Time frame: End of Surgery
Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)
Time frame: 2 hours
Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels
Time frame: end of bypass

Sponsor's own description

Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery. Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Heart Defects, Congenital

Currently open trials in the same condition.

NCT06003023 — Congenital Heart Disease Physical Activity Lifestyle Study V.2 · NA · recruiting
NCT05709470 — Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects · recruiting
NCT05330338 — Genetics of Ventriculo-arterial Discordance · NA · active not recruiting
NCT06089902 — European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries · recruiting

Other Duke University trials

Trials by the same sponsor.

NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation · NA · not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment · NA · not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02485366 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 23 April 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02485366.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing