Post-cardiac SurgeryNCT04980742
Perioperative Risk Factors of Outcomes for Cardiac Surgery: A Retrospective Study
An observational study of Post-cardiac Surgery and Blood Transfusion Complication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, we try to evalute the effect of blood transfusion on outcomes in cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-cardiac Surgery, Blood Transfusion Complication, Prognosis
- What is being tested?
- acute normovolemic hemodilution
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB)
Who may be able to join
- The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB)
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ANH
Hangzhou
Min Yan, doctor, +86-571-87783716, zryanmin@zju.edu.cn
About this study
Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, we try to evalute the effect of blood transfusion on outcomes in cardiac surgery.
Read the detailed description
Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, the following results were obtained:
- Perioperative risk factors of death and complications of different organ systems after cardiac surgery, providing evidence for early prevention and intervention;
- Risk factors of blood transfusion risk were analyzed to provide ideas for reducing intraoperative blood transfusion;
- The relationship between hemoglobin and complications after heart surgery was explored to provide a factual basis for the development of blood transfusion indications for such patients
- Being tested
- acute normovolemic hemodilution
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute normovolemic hemodilutionProcedure or surgery
acute normovolemic hemodilution
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
all-cause death
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jul 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
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 Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980742
- Sponsor's protocol ID
- 2017-111
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Risk Factors of Outcomes for Cardiac Surgery: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04980742
- Acronym / sponsor ID
- 2017-111
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Jul 2021 (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.
Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, we try to evalute the effect of blood transfusion on outcomes in cardiac surgery.
Detailed description
Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, the following results were obtained:
- Perioperative risk factors of death and complications of different organ systems after cardiac surgery, providing evidence for early prevention and intervention;
- Risk factors of blood transfusion risk were analyzed to provide ideas for reducing intraoperative blood transfusion;
- The relationship between hemoglobin and complications after heart surgery was explored to provide a factual basis for the development of blood transfusion indications for such patients
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB)
Key inclusion criteria (1 listed)
- The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB)
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| acute normovolemic hemodilutionacute normovolemic hemodilution | Procedure or surgery | – |
Primary outcome
mortality
Time frame: 28 days after surgery
all-cause death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-cardiac Surgery and Blood Transfusion Complication, 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 28 Jul 2021. 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 Min Yan, doctor (+86-571-87783716, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28 days after surgery). 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 28 Jul 2021.