Heart Valve DiseasesPhase 3NCT05223361
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
A Phase 3 study testing Six percent hydroxy ethyl starch 130/0.4 and Ringer lactate in people with Heart Valve Diseases, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
Trial summary
In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Six percent hydroxy ethyl starch 130/0.4 and Ringer lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- Apr 2016to 30 Nov 2021
- Phase
- Phase 3
- 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
- patients who provided written informed consent and had no heart failure (LVEF >55%), no hepatic failure (defined as aspartate aminotransferase (AST) >40 mg/dL and/or alanine aminotransferase (ALT) >40 mg/dL), no prior history of cardiac surgery, serum creatinine <1.5 mg/dL, no episode of drug-induced acute kidney injury within preoperative 5 days, no severe carotid stenosis in both or one of them, no emergency valvular stenosis, no infective endocarditis, no severe right ventricular failure, no hemoglobin <10 mg/dL, no body mass index >40 kg/m2, no heparin-induced thrombocytopenia, no cancer, no severe pulmonary valve insufficiency, no pulmonary function test <65% before heart valve surgery
Who cannot join
- included consent withdrawal by the patient or by his/her proxy, allergic reaction to the drugs, the aortic cross clamp time greater than 120 minutes, on-pump time greater than 150 minutes, the performance of the retrograde autologous priming.
Trial locations and contacts
1 site in 1 country.
About this study
In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. The first group will receive hydroxyethyl starch (HES) 130/0.4 additive to ringer lactate (RL) and the second group will be given only RL as priming solution. All patients will be observed closely during postoperative days. Through follow up, bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be recorded in both groups.
Read the detailed description
Cardiopulmonary bypass (CPB) pump is a device for circulating blood in the body while the heart is undergone surgery. For providing circulating volume in the body we need to add about 1.5 to 2 lit fluids as priming solution in the CPB pump. Some fluids mainly included crystalloids, colloids, starch, and gelatin in an only fluid or in a combined formula. During CPB time, the blood dilution is caused by adding prime solution into the circulating volume, and consequently it decreases blood viscosity. Moreover, in addition to a decrease in hematocrit level, coagulation factors and plasma proteins can dramatically decreased. These processes may lead to bleeding events and tissue hypoperfusion and organ damages. To decrease complications, some modalities such as adding colloids to crystalloids have been implemented. On the other hand, any regimen for priming solution has its shortcomings need to be considered based on patient condition and surgical issue.
In this double blinded randomized clinical trial study, we aimed to compare the the effects of six percent HES 130/0.4 and RL as priming solutions on coagulation factors, renal function, hepatic function, and cerebral oxygenation in patients undergoing open heart valve surgery.
- Conditions
- Heart Valve Diseases
- Being tested
- Six percent hydroxy ethyl starch 130/0.4, Ringer lactate
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six percent hydroxy ethyl starch 130/0.4Drug
6% HES 130/0.4 additive to ringer lactate as prime solution
Ringer lactateDrug
Ringer lactate as prime solution
| Study group | Role | What they receive |
|---|---|---|
| Hydroxy ethyl starch (HES) | Active comparator | Six percent hydroxy ethyl starch 130/0.4 additive to ringer lactate as priming solution during CPB Receives: Drug: Six percent hydroxy ethyl starch 130/0.4; Drug: Ringer lactate |
| Ringer lactate (RL) | Active comparator | Ringer lactate as priming solution during CPB Receives: Drug: Ringer lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants required blood transfusion
The volume of blood transfusion after heart valve surgery
Measured: Up to discharge, an average of 8 days
Secondary outcomes (15)
Number of participants died in hospital
Any cause of death after heart valve surgery
Measured: Up to discharge, an average of 8 days
Duration of ventilation time
The duration ventilation time after heart valve surgery
Measured: During ICU admission, an average of 2 days
ICU length of stay
The length of stay in intensive care unit
Measured: During ICU admission, an average of 2 days
Hospital length of stay
The length of stay in hospital after heart valve surgery
Measured: During hospital admission, an average of 8 days
Number of participants required chest tube drainage
The amount of drainage from chest tube after heart valve surgery
Measured: During hospital admission, an average of 8 days
Number of participants required re-operation for bleeding
Re-operation due to excessive bleeding after heart valve surgery
Measured: During hospital admission, an average of 8 days
Number of participants died in one month
Any cause of death within one month after heart valve surgery
Measured: One month after surgery
Changes in hemoglobin concentration
Changes in hemoglobin after heart valve surgery
Measured: Up to 48 hours after heart valve surgery
Changes in hematocrit concentration
Changes in hematocrit after heart valve surgery
Measured: Up to 48 hours after heart valve surgery
Changes in serum lactate concentration
Changes in serum lactate after heart valve surgery
Measured: Up to 48 hours after heart valve surgery
Changes in serum blood sugar concentration
Changes in serum blood sugar after heart valve surgery
Measured: Up to 48 hours after heart valve surgery
Number of participants with acute kidney injury
The development of acute kidney injury after heart valve surgery
Measured: Up to 48 hours after heart valve surgery
Changes in liver enzyme concentration
Changes in liver enzyme after heart valve surgery
Measured: Up to 48 hours after heart valve surgery
Amount of cerebral hemispheres' oxygenation
The amount of cerebral oxygenation measured by INVOS in both hemispheres
Measured: During cardiopulmonary bypass time
Changes in coagulation parameters
Changes in coagulation parameters after heart valve surgery
Measured: Up to 48 hours after heart valve surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study startApr 2016
- Primary completion30 Apr 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajaie Cardiovascular Medical and Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Valve Disease Research Center
- Responsible party
- Principal investigator, Rajaie cardiovascular medical & research center, Rajaie Cardiovascular Medical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223361
- Sponsor's protocol ID
- HVDRC-01
- Status last verified
- Jan 2022
- First submitted
- 8 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will decide per request.
Publications
Sheikhi B, Rezaei Y, Baghaei Vaji F, Fatahi M, Hosseini Yazdi M, Totonchi Z, Banar S, Peighambari MM, Hosseini S, Mestres CA. Comparison of six percent hydroxyethyl starch 130/0.4 and ringer's lactate as priming solutions in patients undergoing isolated open heart valve surgery: A double-blind randomized controlled trial. Perfusion. 2025 Jan;40(1):116-124. doi: 10.1177/02676591231222135. Epub 2023 Dec 17.
PubMed 38105566
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT05223361
- Acronym / sponsor ID
- HVDRC-01
- Conditions
- Heart Valve Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rajaie Cardiovascular Medical and Research CenterUniversity, hospital or other
- Collaborators
- Heart Valve Disease Research Center
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 3 Feb 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.
In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. The first group will receive hydroxyethyl starch (HES) 130/0.4 additive to ringer lactate (RL) and the second group will be given only RL as priming solution. All patients will be observed closely during postoperative days. Through follow up, bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be recorded in both groups.
Detailed description
Cardiopulmonary bypass (CPB) pump is a device for circulating blood in the body while the heart is undergone surgery. For providing circulating volume in the body we need to add about 1.5 to 2 lit fluids as priming solution in the CPB pump. Some fluids mainly included crystalloids, colloids, starch, and gelatin in an only fluid or in a combined formula. During CPB time, the blood dilution is caused by adding prime solution into the circulating volume, and consequently it decreases blood viscosity. Moreover, in addition to a decrease in hematocrit level, coagulation factors and plasma proteins can dramatically decreased. These processes may lead to bleeding events and tissue hypoperfusion and organ damages. To decrease complications, some modalities such as adding colloids to crystalloids have been implemented. On the other hand, any regimen for priming solution has its shortcomings need to be considered based on patient condition and surgical issue.
In this double blinded randomized clinical trial study, we aimed to compare the the effects of six percent HES 130/0.4 and RL as priming solutions on coagulation factors, renal function, hepatic function, and cerebral oxygenation in patients undergoing open heart valve surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxy ethyl starch (HES) | Active comparator | Drug: Six percent hydroxy ethyl starch 130/0.4, Drug: Ringer lactateSix percent hydroxy ethyl starch 130/0.4 additive to ringer lactate as priming solution during CPB |
| Ringer lactate (RL) | Active comparator | Drug: Ringer lactateRinger lactate as priming solution during CPB |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who provided written informed consent and had no heart failure (LVEF >55%), no hepatic failure (defined as aspartate aminotransferase (AST) >40 mg/dL and/or alanine aminotransferase (ALT) >40 mg/dL), no prior history of cardiac surgery, serum creatinine <1.5 mg/dL, no episode of drug-induced acute kidney injury within preoperative 5 days, no severe carotid stenosis in both or one of them, no emergency valvular stenosis, no infective endocarditis, no severe right ventricular failure, no hemoglobin <10 mg/dL, no body mass index >40 kg/m2, no heparin-induced thrombocytopenia, no cancer, no severe pulmonary valve insufficiency, no pulmonary function test <65% before heart valve surgery
Key exclusion criteria (1 listed)
- included consent withdrawal by the patient or by his/her proxy, allergic reaction to the drugs, the aortic cross clamp time greater than 120 minutes, on-pump time greater than 150 minutes, the performance of the retrograde autologous priming.
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 |
|---|---|---|
| Six percent hydroxy ethyl starch 130/0.46% HES 130/0.4 additive to ringer lactate as prime solution | Drug | Hydroxy ethyl starch (HES) |
| Ringer lactateRinger lactate as prime solution | Drug | Hydroxy ethyl starch (HES), Ringer lactate (RL) |
Primary outcome
Number of participants required blood transfusion
Time frame: Up to discharge, an average of 8 days
The volume of blood transfusion after heart valve surgery
15 secondary outcomes
Number of participants died in hospital
Time frame: Up to discharge, an average of 8 days
Duration of ventilation time
Time frame: During ICU admission, an average of 2 days
ICU length of stay
Time frame: During ICU admission, an average of 2 days
Hospital length of stay
Time frame: During hospital admission, an average of 8 days
Number of participants required chest tube drainage
Time frame: During hospital admission, an average of 8 days
Number of participants required re-operation for bleeding
Time frame: During hospital admission, an average of 8 days
Number of participants died in one month
Time frame: One month after surgery
Changes in hemoglobin concentration
Time frame: Up to 48 hours after heart valve surgery
Changes in hematocrit concentration
Time frame: Up to 48 hours after heart valve surgery
Changes in serum lactate concentration
Time frame: Up to 48 hours after heart valve surgery
Changes in serum blood sugar concentration
Time frame: Up to 48 hours after heart valve surgery
Number of participants with acute kidney injury
Time frame: Up to 48 hours after heart valve surgery
Changes in liver enzyme concentration
Time frame: Up to 48 hours after heart valve surgery
Amount of cerebral hemispheres' oxygenation
Time frame: During cardiopulmonary bypass time
Changes in coagulation parameters
Time frame: Up to 48 hours after heart valve surgery
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 3 Feb 2022.
- Derived from this study: PubMed 38105566Sheikhi B, Rezaei Y, Baghaei Vaji F, Fatahi M, Hosseini Yazdi M, Totonchi Z, Banar S, Peighambari MM, Hosseini S, Mestres CA. Comparison of six percent hydroxyethyl starch 130/0.4 and ringer's lactate as priming solutions in patients undergoing isolated open heart valve surgery: A double-blind randomized controlled trial. Perfusion. 2025 Jan;40(1):116-124. doi: 10.1177/02676591231222135. Epub 2023 Dec 17.
- Individual participant dataSharing planned: Undecided. We will decide per request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Six percent hydroxy ethyl starch 130/0.4 and Ringer lactate in people with Heart Valve Diseases, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
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 3 Feb 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants required blood transfusion (time frame: Up to discharge, an average of 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223361, which also lists 1 linked publication.
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 3 Feb 2022.