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

Not Applicable

• Conditions: Red Blood Cell Disorder
• Interventions: Combination Product: blood preservation solution III

• Registration Number: NCT05267145
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2022-02-24
• Study Start: 2022-03-01
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Primary Completion: 2022-06-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Elective median incision for cardiac surgery under CPB ASAⅠ~Ⅲ 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the blood storage bag contains blood preservation solution III	blood preservation solution III	a blood storage bag containing blood preservation solution III preserves the washed RBC

Primary Outcome Measures

Name	Time	Method
hemoglobin and free hemoglobin concentrations	up to 48 hours	hemoglobin and free hemoglobin concentrations in both groups

Secondary Outcome Measures

Name	Time	Method
RBC morphology	autologous blood transfusion immediately, 24 hours, 48 hours	erythrocyte morphology was observed by Rayner's staining and examined under microscope
Adenosine acid (ATP ADP AMP) content in RBC	autologous blood transfusion immediately, 24 hours, 48 hours	the clarified supernatants were used for ATP, ADP, and AMP measurements with kits
2, 3-diphosphate (2,3-DPG) concentration	autologous blood transfusion immediately, 24 hours, 48 hours	the cellular 2,3-DPG was analyzed fluorometrically with a kit

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department; 🇨🇳 Hangzhou, Zhejiang, China