Cardiac Surgery SubjectsNCT07634042
Ionized Calcium and Bleeding in Cardiac Surgery
An observational study of Cardiac Surgery Subjects, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This retrospective study investigates the association between perioperative plasma ionized calcium concentration and perioperative bleeding in open-heart surgery. Excluding patients who meet exclusion criteria, the study will include all applicable adult patients who underwent cardiac surgery at Helsinki University… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Surgery Subjects
- How many people
- 4,300 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult (age 18-100 years) patients who underwent open-heart surgery with cardiopulmonary bypass (surgery with a main procedure code in the NCSP classification F category, "Heart and Great Vessels of the Thorax", performed on extracorporeal perfusion, procedure code FXA00) in Helsinki University Hospital between January 2021 and March 2026. Exclusion Criteria: Organ transplants (procedure code FQ), hemophilia, von Willebrand disease, or platelet function disorders (ICD-10 codes D65-D69) and essential thrombocythemia (ICD-10 code D75.2).
Who may be able to join
- age 18-100 years
- open-heart surgery with cardiopulmonary bypass (surgery with a main procedure code in the NCSP classification F category, "Heart and Great Vessels of the Thorax", performed on extracorporeal perfusion, procedure code FXA00)
- between January 2021 and March 2026
Who cannot join
- organ transplants (procedure code FQ)
- hemophilia, von Willebrand disease, or platelet function disorders (ICD-10 codes D65-D69)
- essential thrombocythemia (ICD-10 code D75.2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Helsinki University Hospital, Meilahti Hospital
Helsinki, 00029 HUS
Eero Pesonen, MD, PhD, docent, +358-40-5880781, eero.pesonen@hus.fi
Eero Pesonen, MD, PhD, docent
About this study
Official title: Plasma Ionized Calcium and Perioperative Bleeding in Cardiac Surgery.
This retrospective study investigates the association between perioperative plasma ionized calcium concentration and perioperative bleeding in open-heart surgery. Excluding patients who meet exclusion criteria, the study will include all applicable adult patients who underwent cardiac surgery at Helsinki University Hospital between January 2021 and March 2026. As clinical routine, during both cardiac surgery and the subsequent intensive care period, multiple blood gas analyses were performed, including measurements of plasma ionized calcium concentration. Time-weighted averages of all measurements will be calculated across different phases of surgery (pre-CPB, on -CPB, post-CPB) and the first 24 hours of ICU stay (0-6 h, 6-12 h, 12-24 h). Perioperative bleeding will be assessed using the Universal Definition of Perioperative Bleeding (UDPB) classification validated for cardiac surgery. In addition to chest drain output, this classification accounts for blood products administered to treat bleeding (red blood cells, platelets, and fresh frozen plasma), pharmacological coagulation factor concentrates (fibrinogen/cryoprecipitate, PCC, aFVIIa) and surgical interventions (open sternum, resternotomy). The association between plasma ionized calcium and UDPB class will be assessed with regression models. The primary analysis will be the association between time-weighted mean plasma ionized calcium level during the post-CPB phase as a continuous variable and dichotomous UDPB (UDPB 3-4 vs. UDPB 0-2) in patients who did not receive blood products during the post-CPB phase. One secondary and two sensitivity analyses will be performed
Read the detailed description
PERIOPERATIVE TIME STAMPS: The perioperative phase is divided into the following time periods: the operating room phase before cardiopulmonary bypass (pre-CPB), cardiopulmonary bypass (on-CPB), the operating room phase after cardiopulmonary bypass (post-CPB), 0-6 hours in the intensive care unit (ICU-0-6h), 6-12 hours in the intensive care unit (ICU-6-12h), and 12-24 hours in the intensive care unit (ICU-12-24h). If the patient is transferred from the intensive care unit to the ward earlier than 24 hours after surgery, the final time period ends at the time of transfer.
PRIMARY ANALYSIS: The association between time-weighted mean plasma ionized calcium concentration during the post-CPB phase as a continuous variable and dichotomous UDPB (UDPB 3-4 vs. UDPB 0-2) in patients who did not receive blood products during the post-CPB phase. SECONDARY ANALYSIS: The association between time-weighted mean plasma ionized calcium concentration during the post-CPB phase as a continuous variable and the original five-grade UDPB in patients who did not receive blood products during the post-CPB phase. SENSITIVITY ANALYSES: The corresponding analyses to the primary and secondary analyses including all patients.
STATISTICAL ANALYSES: Differences in continuous variables between two groups will be tested using Student's t-test, and correlations between continuous variables will be assessed using Pearson's correlation test. The association between two dichotomous variables will be analyzed using Pearson's chi-square test. Temporal changes in plasma ionized calcium concentration across the entire study population will be analyzed using one-way analysis of variance (ANOVA). Post hoc comparisons will be performed using Dunnett's test, in which perioperative plasma ionized calcium concentrations will be compared with pre-CPB values. The association between plasma ionized calcium and UDPB class will be assessed with regression models. In addition to the primary, secondary and sensitivity analyses, corresponding multivariable analyses will be performed adjusted for clinical risk factors for bleeding. The clinical risk factors included in the model will be those previously identified by the research group among cardiac surgery patients at Meilahti Hospital. Multicollinearity among explanatory variables in the multivariable models will be considered present if the variance inflation factor (VIF) exceeds 5. In the presence of multicollinearity, the variable considered more clinically relevant for the model will be prioritized, and secondarily, the variable showing the stronger univariable association with the outcome will be selected. Otherwise, all predefined explanatory variables will be included in the multivariable model regardless of their statistical significance in univariable analyses. If needed, the five-grade UDPB will be modified to meet the assumption for proportional odds in ordinal regression models. Linearity will be tested. If needed, non-linear modeling will be used. The extent of missing data is not known at the time of writing the study protocol. The need for imputation of missing data and the specific imputation methodology will be evaluated after the study dataset has been obtained. Results will be presented as means and standard deviations, frequencies and proportions, or odds ratios with 95% confidence intervals (CI). A two-sided p-value < 0.05 will be considered statistically significant.
- Conditions
- Cardiac Surgery Subjects
- Keywords
- cardiac surgery, cardiopulmonary bypass, plasma ionized calcium, bleeding, perioperative bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult patients undergoing cardiac surgery with cardiopulmonary bypass | All adult (age 18-100 years) patients who underwent open-heart surgery with cardiopulmonary bypass (surgery with a main procedure code in the NCSP classification F category, "Heart and Great Vessels of the Thorax", performed on extracorporeal perfusion, procedure code FXA00) in Helsinki University Hospital between January 2021 and March 2026. Exclusion Criteria: Organ transplants (procedure code FQ), hemophilia, von Willebrand disease, or platelet function disorders (ICD-10 codes D65-D69) and essential thrombocythemia (ICD-10 code D75.2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted plasma ionized calcium concentration during the post-CPB phase in OR for the primary and secondary analyses.
Time-weighted plasma ionized calcium concentration as a continuous parameter during the post-CPB phase in OR (i.e., the time interval between the cessation of CPB and the exit from OR) in the patients who did not receive blood products during the post-CPB phase.
Measured: The time interval between the cessation of CPB and the exit from OR.
Dichotomized UDPB (Universal Definition of Perioperative Bleeding).
UDPB (Universal Definition of Perioperative Bleeding) as a measure of perioperative bleeding and dichotomized into UDPB 0-2 vs. UDPB 3-4 in the patients who did not receive blood products during the post-CPB phase.
Measured: From the cessation of CPB till the end of the first 24 postoperative hours in ICU or till the exit from ICU, whichever occurred first.
Secondary outcomes (1)
Original five-grade UDPB (Universal Definition of Perioperative Bleeding).
Five-grade UDPB (Universal Definition of Perioperative Bleeding) as a measure of perioperative bleeding in the patients who did not receive blood products during the post-CPB phase.
Measured: From the cessation of CPB till the end of the first 24 postoperative hours in ICU or till the exit from ICU, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery SubjectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eero Pesonen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634042
- Sponsor's protocol ID
- 04934
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: EU and national legislation restrict the distribution of personal health data. No data is available outside the authorized use within the HUS Acamedic or Findata platforms.
Publications
Talvasto A, Ilmakunnas M, Raivio P, Vlasov H, Hiippala S, Suojaranta R, Wilkman E, Petaja L, Helve O, Juvonen T, Pesonen E. Albumin Infusion and Blood Loss After Cardiac Surgery. Ann Thorac Surg. 2023 Aug;116(2):392-399. doi: 10.1016/j.athoracsur.2023.03.041. Epub 2023 Apr 27.
PubMed 37120084Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9.
PubMed 24332097
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Ionized Calcium and Perioperative Bleeding in Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT07634042
- Acronym / sponsor ID
- 04934
- Conditions
- Cardiac Surgery Subjects
- Keywords
- cardiac surgery, cardiopulmonary bypass, plasma ionized calcium, bleeding, perioperative bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,300 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Jun 2026 (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.
This retrospective study investigates the association between perioperative plasma ionized calcium concentration and perioperative bleeding in open-heart surgery. Excluding patients who meet exclusion criteria, the study will include all applicable adult patients who underwent cardiac surgery at Helsinki University Hospital between January 2021 and March 2026. As clinical routine, during both cardiac surgery and the subsequent intensive care period, multiple blood gas analyses were performed, including measurements of plasma ionized calcium concentration. Time-weighted averages of all measurements will be calculated across different phases of surgery (pre-CPB, on -CPB, post-CPB) and the first 24 hours of ICU stay (0-6 h, 6-12 h, 12-24 h). Perioperative bleeding will be assessed using the Universal Definition of Perioperative Bleeding (UDPB) classification validated for cardiac surgery. In addition to chest drain output, this classification accounts for blood products administered to treat bleeding (red blood cells, platelets, and fresh frozen plasma), pharmacological coagulation factor concentrates (fibrinogen/cryoprecipitate, PCC, aFVIIa) and surgical interventions (open sternum, resternotomy). The association between plasma ionized calcium and UDPB class will be assessed with regression models. The primary analysis will be the association between time-weighted mean plasma ionized calcium level during the post-CPB phase as a continuous variable and dichotomous UDPB (UDPB 3-4 vs. UDPB 0-2) in patients who did not receive blood products during the post-CPB phase. One secondary and two sensitivity analyses will be performed
Detailed description
PERIOPERATIVE TIME STAMPS: The perioperative phase is divided into the following time periods: the operating room phase before cardiopulmonary bypass (pre-CPB), cardiopulmonary bypass (on-CPB), the operating room phase after cardiopulmonary bypass (post-CPB), 0-6 hours in the intensive care unit (ICU-0-6h), 6-12 hours in the intensive care unit (ICU-6-12h), and 12-24 hours in the intensive care unit (ICU-12-24h). If the patient is transferred from the intensive care unit to the ward earlier than 24 hours after surgery, the final time period ends at the time of transfer.
PRIMARY ANALYSIS: The association between time-weighted mean plasma ionized calcium concentration during the post-CPB phase as a continuous variable and dichotomous UDPB (UDPB 3-4 vs. UDPB 0-2) in patients who did not receive blood products during the post-CPB phase. SECONDARY ANALYSIS: The association between time-weighted mean plasma ionized calcium concentration during the post-CPB phase as a continuous variable and the original five-grade UDPB in patients who did not receive blood products during the post-CPB phase. SENSITIVITY ANALYSES: The corresponding analyses to the primary and secondary analyses including all patients.
STATISTICAL ANALYSES: Differences in continuous variables between two groups will be tested using Student's t-test, and correlations between continuous variables will be assessed using Pearson's correlation test. The association between two dichotomous variables will be analyzed using Pearson's chi-square test. Temporal changes in plasma ionized calcium concentration across the entire study population will be analyzed using one-way analysis of variance (ANOVA). Post hoc comparisons will be performed using Dunnett's test, in which perioperative plasma ionized calcium concentrations will be compared with pre-CPB values. The association between plasma ionized calcium and UDPB class will be assessed with regression models. In addition to the primary, secondary and sensitivity analyses, corresponding multivariable analyses will be performed adjusted for clinical risk factors for bleeding. The clinical risk factors included in the model will be those previously identified by the research group among cardiac surgery patients at Meilahti Hospital. Multicollinearity among explanatory variables in the multivariable models will be considered present if the variance inflation factor (VIF) exceeds 5. In the presence of multicollinearity, the variable considered more clinically relevant for the model will be prioritized, and secondarily, the variable showing the stronger univariable association with the outcome will be selected. Otherwise, all predefined explanatory variables will be included in the multivariable model regardless of their statistical significance in univariable analyses. If needed, the five-grade UDPB will be modified to meet the assumption for proportional odds in ordinal regression models. Linearity will be tested. If needed, non-linear modeling will be used. The extent of missing data is not known at the time of writing the study protocol. The need for imputation of missing data and the specific imputation methodology will be evaluated after the study dataset has been obtained. Results will be presented as means and standard deviations, frequencies and proportions, or odds ratios with 95% confidence intervals (CI). A two-sided p-value < 0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients undergoing cardiac surgery with cardiopulmonary bypass | – | –All adult (age 18-100 years) patients who underwent open-heart surgery with cardiopulmonary bypass (surgery with a main procedure code in the NCSP classification F category, "Heart and Great Vessels of the Thorax", performed on extracorporeal perfusion, procedure code FXA00) in Helsinki University Hospital between January 2021 and March 2026. Exclusion Criteria: Organ transplants (procedure code FQ), hemophilia, von Willebrand disease, or platelet function disorders (ICD-10 codes D65-D69) and essential thrombocythemia (ICD-10 code D75.2). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (age 18-100 years) patients who underwent open-heart surgery with cardiopulmonary bypass (surgery with a main procedure code in the NCSP classification F category, "Heart and Great Vessels of the Thorax", performed on extracorporeal perfusion, procedure code FXA00) in Helsinki University Hospital between January 2021 and March 2026. Exclusion Criteria: Organ transplants (procedure code FQ), hemophilia, von Willebrand disease, or platelet function disorders (ICD-10 codes D65-D69) and essential thrombocythemia (ICD-10 code D75.2).
Key inclusion criteria (3 listed)
- age 18-100 years
- open-heart surgery with cardiopulmonary bypass (surgery with a main procedure code in the NCSP classification F category, "Heart and Great Vessels of the Thorax", performed on extracorporeal perfusion, procedure code FXA00)
- between January 2021 and March 2026
Key exclusion criteria (3 listed)
- organ transplants (procedure code FQ)
- hemophilia, von Willebrand disease, or platelet function disorders (ICD-10 codes D65-D69)
- essential thrombocythemia (ICD-10 code D75.2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time-weighted plasma ionized calcium concentration during the post-CPB phase in OR for the primary and secondary analyses.
Time frame: The time interval between the cessation of CPB and the exit from OR.
Time-weighted plasma ionized calcium concentration as a continuous parameter during the post-CPB phase in OR (i.e., the time interval between the cessation of CPB and the exit from OR) in the patients who did not receive blood products during the post-CPB phase.
Dichotomized UDPB (Universal Definition of Perioperative Bleeding).
Time frame: From the cessation of CPB till the end of the first 24 postoperative hours in ICU or till the exit from ICU, whichever occurred first.
UDPB (Universal Definition of Perioperative Bleeding) as a measure of perioperative bleeding and dichotomized into UDPB 0-2 vs. UDPB 3-4 in the patients who did not receive blood products during the post-CPB phase.
1 secondary outcome
Original five-grade UDPB (Universal Definition of Perioperative Bleeding).
Time frame: From the cessation of CPB till the end of the first 24 postoperative hours in ICU or till the exit from ICU, whichever occurred first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 37120084Talvasto A, Ilmakunnas M, Raivio P, Vlasov H, Hiippala S, Suojaranta R, Wilkman E, Petaja L, Helve O, Juvonen T, Pesonen E. Albumin Infusion and Blood Loss After Cardiac Surgery. Ann Thorac Surg. 2023 Aug;116(2):392-399. doi: 10.1016/j.athoracsur.2023.03.041. Epub 2023 Apr 27.
- Background: PubMed 24332097Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9.
- Individual participant dataSharing planned: No. EU and national legislation restrict the distribution of personal health data. No data is available outside the authorized use within the HUS Acamedic or Findata platforms.
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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.
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 Cardiac Surgery Subjects, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Jun 2026. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eero Juhani Pesonen, MD, PhD, docent (+358-40-5880781, eero.pesonen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted plasma ionized calcium concentration during the post-CPB phase in OR for the primary and secondary analyses. (time frame: The time interval between the cessation of CPB and the exit from OR.). The study lists 2 primary outcomes in all. 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 NCT07634042, which also lists 2 linked publications.
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 Jun 2026.