Cardiac SurgeryNCT04369443
Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
A study testing Large volume Acute Normovolemic Hemodilution in people with Cardiac Surgery and Acute Normovolemic Hemodilution, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Surgery, Acute Normovolemic Hemodilution
- What is being tested?
- Large volume Acute Normovolemic Hemodilution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Jan 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- （1）18-75years old;（2）elective cardiac surgery under cardiopulmonary bypass; （3）Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).
Who cannot join
- （1）congenital heart disease、Cardiac tumor、aortic dissection、heart transplantation（2）Low body weight（<50 kg）;（3）preoperative shock；（4）myocardial infarction within 3 months before surgery；（5）ischemic heart disease;Left main coronary artery stenosis >70%;Severe aortic stenosis (area < 0.7cm2);Severe changes in left ventricular function (ejection fraction <30%, requiring vasoactive agents to assist circulation);（6）severe carotid artery stenosis (>70% or with symptoms);（7） kidney failure (blood creatinine level >442 mmol/L) or dialysis treatment;（8） serum albumin level (ALB) is less than 25 g/L.（9） international standardized ratio (INR) >1.5 or platelet count <100 103/mm3;（10）Inherited/acquired coagulation function defect;（11）contagious or infectious diseases;（12） patient or family members refused to participate in research;（13）refused to infusion of autologous blood or allogeneic blood products
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
About this study
The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent
- Conditions
- Cardiac Surgery, Acute Normovolemic Hemodilution
- Being tested
- Large volume Acute Normovolemic Hemodilution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large volume Acute Normovolemic HemodilutionProcedure or surgery
Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed.
| Study group | Role | What they receive |
|---|---|---|
| MANH | No intervention | Not described |
| LANH | Experimental | Not described Receives: Procedure: Large volume Acute Normovolemic Hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of allogeneic blood transfusion
The mean volume of allogeneic blood transfusion
Measured: Through study completion，about 8 months
Secondary outcomes (4)
Rate of postoperative cardiac complications
Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination
Measured: Through study completion，about 8 months
Rate of postoperative pulmonary complications
Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination
Measured: Through study completion，about 8 months
Rate of postoperative renal complication
Acute kidney injury or Need renal replacement therapy
Measured: Through study completion，about 8 months
Other severe complication
Including re-operation, re-admission of intensive care unit, multiple organ dysfunction, all cause death according to physical and laboratory examination and medical record
Measured: Through study completion，about 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 May 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Doctor, Study chair, The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China, 310000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369443
- Sponsor's protocol ID
- 2020-110
- Status last verified
- May 2020
- First submitted
- 28 Apr 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04369443
- Acronym / sponsor ID
- 2020-110
- Conditions
- Cardiac Surgery, Acute Normovolemic Hemodilution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 30 Apr 2020 (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.
The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MANH | No intervention | – |
| LANH | Experimental | Procedure: Large volume Acute Normovolemic Hemodilution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- （1）18-75years old;（2）elective cardiac surgery under cardiopulmonary bypass; （3）Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).
Key exclusion criteria (1 listed)
- （1）congenital heart disease、Cardiac tumor、aortic dissection、heart transplantation（2）Low body weight（<50 kg）;（3）preoperative shock；（4）myocardial infarction within 3 months before surgery；（5）ischemic heart disease;Left main coronary artery stenosis >70%;Severe aortic stenosis (area < 0.7cm2);Severe changes in left ventricular function (ejection fraction <30%, requiring vasoactive agents to assist circulation);（6）severe carotid artery stenosis (>70% or with symptoms);（7） kidney failure (blood creatinine level >442 mmol/L) or dialysis treatment;（8） serum albumin level (ALB) is less than 25 g/L.（9） international standardized ratio (INR) >1.5 or platelet count <100 103/mm3;（10）Inherited/acquired coagulation function defect;（11）contagious or infectious diseases;（12） patient or family members refused to participate in research;（13）refused to infusion of autologous blood or allogeneic blood products
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 |
|---|---|---|
| Large volume Acute Normovolemic HemodilutionFollowing induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed. | Procedure or surgery | LANH |
Primary outcome
Volume of allogeneic blood transfusion
Time frame: Through study completion，about 8 months
The mean volume of allogeneic blood transfusion
4 secondary outcomes
Rate of postoperative cardiac complications
Time frame: Through study completion，about 8 months
Rate of postoperative pulmonary complications
Time frame: Through study completion，about 8 months
Rate of postoperative renal complication
Time frame: Through study completion，about 8 months
Other severe complication
Time frame: Through study completion，about 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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, Doctor study chair
The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China, 310000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large volume Acute Normovolemic Hemodilution in people with Cardiac Surgery and Acute Normovolemic Hemodilution, 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: finished, as of the sponsor's last update on 8 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of allogeneic blood transfusion (time frame: Through study completion，about 8 months). 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 8 Feb 2023.