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

March 3, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University anesthesiology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: the blood storage bag contains blood preservation solution III
a blood storage bag containing blood preservation solution III preserves the washed RBC
Combination product: blood preservation solution III
Blood bag added blood preservation solution III
NO_INTERVENTION: empty blood bag to store washed RBC
an empty blood storage bag preserves the washed RBC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RBC morphology
Time Frame: autologous blood transfusion immediately, 24 hours, 48 hours
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
Time Frame: autologous blood transfusion immediately, 24 hours, 48 hours
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
Time Frame: autologous blood transfusion immediately, 24 hours, 48 hours
the cellular 2,3-DPG was analyzed fluorometrically with a kit
autologous blood transfusion immediately, 24 hours, 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Min Yan, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (ACTUAL)

March 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-0347

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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