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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Red Blood Cell Disorder

Intervention / Treatment
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* Combination Product: blood preservation solution III


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the blood storage bag contains blood preservation solution III<br>a blood storage bag containing blood preservation solution III preserves the washed RBC | Combination Product: blood preservation solution III<br>* Blood bag added blood preservation solution III<br>|
| No Intervention: empty blood bag to store washed RBC<br>an empty blood storage bag preserves the washed RBC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin and free hemoglobin concentrations | hemoglobin and free hemoglobin concentrations in both groups | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC morphology | erythrocyte morphology was observed by Rayner's staining and examined under microscope | autologous blood transfusion immediately, 24 hours, 48 hours | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood preservation solution III, intraoperative blood salvage