Clinical Use of Pathogen Reduced Red Blood Cell Suspension

Status Completed

Clinical Trial Summary

The aim of the study is to evaluate the effectiveness and safety of the application of pathogen inactivated RBC suspension in children with oncological and hematological diseases.

Clinical Trial Description

Assumed scope of study:

The study will include 70 patients: 35 patients to the test group, who will get transfusions with pathogen-inactivated red blood cell suspension; 35 patients to the control group, who will get transfusions with irradiated red blood cell suspension.

Methods:

- Selection of patients suitable to participate in the study.

- A few days before the assumed transfusion date, select/prepare a red blood cell suspension corresponding to ABO and Rh systems, with no more than 14 days of storage. Conduct direct antiglobuline test (DAT), indirect antiglobuline test (IAT) and test for individual compatibility with the patient's serum.

- Before performing transfusion (on the day of transfusion), determine the initial indices of the patient (Hb, Hct, Haptoglobin). Determine the red blood cell suspension indices (Hb, Hct, extracellular potassium, free hemoglobin, hemolysis percentage).

- Perform transfusion. Evaluate the presence and severity of post-transfusion reactions and complications.

- Measure the patient's Hb, Hct, potassium and haptoglobin levels the next day after the transfusion.

- Perform DAT 3 to 5 five days after the transfusion.

- Perform IAT 2 to 3 weeks after the transfusion.

- Evaluate the need for transfusions over the follow-up period (30 days). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03426553
Study type	Interventional
Source	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Contact
Status	Completed
Phase	Phase 3
Start date	January 15, 2018
Completion date	December 17, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04094844` - Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation	N/A
Completed	`NCT04474678` - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")	N/A
Recruiting	`NCT03918343` - Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation	N/A
Completed	`NCT01445561` - Ultra Low Dose Interleukin-2 in Healthy Volunteers	Phase 1
Recruiting	`NCT06148610` - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Completed	`NCT04168983` - Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy	N/A
Not yet recruiting	`NCT05969821` - Clonal Hematopoiesis of Immunological Significance
Withdrawn	`NCT04282174` - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies	Phase 2
Completed	`NCT01108159` - Integrated Whole-Genome Analysis of Hematologic Disorders
Completed	`NCT00800839` - Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide	Phase 2
Completed	`NCT00213239` - A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children	Phase 1/Phase 2
Terminated	`NCT00208949` - A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF	Phase 2
Terminated	`NCT00176826` - T-Cell Depletion and Stem Cell Transplant for Immune Deficiencies and Histiocytic Disorders	Phase 2/Phase 3
Completed	`NCT00208962` - Allogeneic Cell Therapy for Adults With Hematologic Malignancies	Phase 2
Completed	`NCT00000603` - Cord Blood Stem Cell Transplantation Study (COBLT)	Phase 2
Completed	`NCT00000587` - Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection	Phase 2
Active, not recruiting	`NCT03655678` - A Safety and Efficacy Study Evaluating CTX001 in Subjects With Transfusion-Dependent β-Thalassemia	Phase 2/Phase 3
Recruiting	`NCT05487794` - Effect of Dose Fractionation of Testosterone Cypionate on Transgender Men With Erythrocytosis	N/A
Completed	`NCT03611257` - Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases	N/A
Completed	`NCT02827149` - High Resolution Donor Recipient HLA Matching Level in Unrelated HSCT