The Protection of ACD III on Erythrocytes in Intraoperative Blood Salvage During Cardiopulmonary Bypass
The Protection of Blood Preservation Solution III on Erythrocytes in Intraoperative Blood Salvage During Cardiopulmonary Bypass
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedMarch 4, 2022
December 1, 2021
3 months
February 24, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemoglobin and free hemoglobin concentrations
hemoglobin and free hemoglobin concentrations in both groups
up to 48 hours
Secondary Outcomes (3)
RBC morphology
autologous blood transfusion immediately, 24 hours, 48 hours
Adenosine acid (ATP ADP AMP) content in RBC
autologous blood transfusion immediately, 24 hours, 48 hours
2, 3-diphosphate (2,3-DPG) concentration
autologous blood transfusion immediately, 24 hours, 48 hours
Study Arms (2)
the blood storage bag contains blood preservation solution III
EXPERIMENTALa blood storage bag containing blood preservation solution III preserves the washed RBC
empty blood bag to store washed RBC
NO INTERVENTIONan empty blood storage bag preserves the washed RBC
Interventions
Blood bag added blood preservation solution III
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000, China
Study Officials
- PRINCIPAL INVESTIGATOR
Min Yan
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Central Study Contacts
Min Yan
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2022
First Posted
March 4, 2022
Study Start
March 1, 2022
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
March 4, 2022
Record last verified: 2021-12