Red Blood Cell DisorderNCT05267145
The Protection of ACD III on Erythrocytes in Intraoperative Blood Salvage During Cardiopulmonary Bypass
A study testing blood preservation solution III in people with Red Blood Cell Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Red Blood Cell Disorder
- What is being tested?
- blood preservation solution III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Min Yan contact
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, zryanmin@zju.edu.cn
About this study
Official title: 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
Read the 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.
- Conditions
- Red Blood Cell Disorder
- Being tested
- blood preservation solution III
- Keywords
- blood preservation solution III, intraoperative blood salvage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood preservation solution IIICombination product
Blood bag added blood preservation solution III
| Study group | Role | What they receive |
|---|---|---|
| the blood storage bag contains blood preservation solution III | Experimental | a blood storage bag containing blood preservation solution III preserves the washed RBC Receives: Combination Product: blood preservation solution III |
| empty blood bag to store washed RBC | No intervention | an empty blood storage bag preserves the washed RBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin and free hemoglobin concentrations
hemoglobin and free hemoglobin concentrations in both groups
Measured: up to 48 hours
Secondary outcomes (3)
RBC morphology
erythrocyte morphology was observed by Rayner's staining and examined under microscope
Measured: 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
Measured: 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
Measured: autologous blood transfusion immediately, 24 hours, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red Blood Cell DisorderStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267145
- Sponsor's protocol ID
- 2021-0347
- Status last verified
- Dec 2021
- First submitted
- 24 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protection of Blood Preservation Solution III on Erythrocytes in Intraoperative Blood Salvage During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05267145
- Acronym / sponsor ID
- 2021-0347
- Conditions
- Red Blood Cell Disorder
- Keywords
- blood preservation solution III, intraoperative blood salvage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the blood storage bag contains blood preservation solution III | Experimental | Combination Product: blood preservation solution IIIa blood storage bag containing blood preservation solution III preserves the washed RBC |
| empty blood bag to store washed RBC | No intervention | –an empty blood storage bag preserves the washed RBC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood preservation solution IIIBlood bag added blood preservation solution III | Combination product | the blood storage bag contains blood preservation solution III |
Primary outcome
hemoglobin and free hemoglobin concentrations
Time frame: up to 48 hours
hemoglobin and free hemoglobin concentrations in both groups
3 secondary outcomes
RBC morphology
Time frame: 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
2, 3-diphosphate (2,3-DPG) concentration
Time frame: autologous blood transfusion immediately, 24 hours, 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Yan contact
Min Yan principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood preservation solution III in people with Red Blood Cell Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingxia Liu (17318531819, liu17318531819@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin and free hemoglobin concentrations (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.