The Protection of ACD III on Erythrocytes in Intraoperative Blood Salvage During Cardiopulmonary Bypass

Red Blood Cell Disorder Clinical Trial

Official title:

The Protection of Blood Preservation Solution III on Erythrocytes in Intraoperative Blood Salvage During Cardiopulmonary Bypass

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05267145
• Other study ID #: 2021-0347
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Mingxia Liu
• Phone: 17318531819
• Email: liu17318531819[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of blood preservation solution III (sodium citrate, sodium dihydrogen phosphate, sodium citrate, glucose and adenine) in autologous blood recovery and storage bags on the metabolic morphological functions and characteristics of red blood cells in patients undergoing cardiac surgery supported by cardiopulmonary bypass

Description:

Blood preservation solution III is a blood protective solution clinically used to store whole blood and red blood cells. It is a sterilized aqueous solution composed of sodium citrate dihydrogen phosphate sodium citrate glucose and adenine, in which glucose adenine can provide the required energy for stored RBC. Citric acid/sodium citrate buffer pair can adjust the pH of RBC suspension; Sodium dihydrogen phosphate can prevent RBC aggregation, provide phosphate for RBC energy metabolism, and slow down the decline rate of 2,3-DPG. Blood preservation solution III can reduce RBC destruction and protect its function. Therefore, this study aims to explore the effect of adding blood preservation solution III in blood storage bags on CPB Influence of autologous blood recovery RBC during cardiac surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Elective median incision for cardiac surgery under CPB ASA?~? Intraoperative blood recovery is pollution-free No blood system diseases, no red blood cell related diseases Preoperative blood routine examination showed no obvious abnormalities in blood coagulation function and biochemistry

Exclusion Criteria:

• Patients have malignant tumor Patients are complicated with systemic infectious disease Intraoperative blood loss is expected to be less than 200ml Patients receiving allogeneic red blood cells during operation

Related Conditions & MeSH terms

• Red Blood Cell Disorder

Intervention

Combination Product:
• blood preservation solution III
Blood bag added blood preservation solution III

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin and free hemoglobin concentrations	hemoglobin and free hemoglobin concentrations in both groups	up to 48 hours
Secondary	RBC morphology	erythrocyte morphology was observed by Rayner's staining and examined under microscope	autologous blood transfusion immediately, 24 hours, 48 hours
Secondary	Adenosine acid (ATP ADP AMP) content in RBC	the clarified supernatants were used for ATP, ADP, and AMP measurements with kits	autologous blood transfusion immediately, 24 hours, 48 hours
Secondary	2, 3-diphosphate (2,3-DPG) concentration	the cellular 2,3-DPG was analyzed fluorometrically with a kit	autologous blood transfusion immediately, 24 hours, 48 hours