Ionized Calcium and Bleeding in Cardiac Surgery
ConditionCardiac Surgery Subjects
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorHelsinki University Central Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
4,300 Participants
are grouped into 1 trial groupGroup A: adult patients undergoing cardiac surgery with cardiopulmonary bypass
Trial outcomes
Primary outcomes
1
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.
Time frame
The time interval between the cessation of CPB and the exit from OR.2
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.
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.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.
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.Other outcomes
1
Time-weighted plasma ionized calcium concentration during the post-CPB phase in OR for both sensitivity analyses of all patients.
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 all patients.
Time frame
The time interval between the cessation of CPB and the exit from OR.2
Sensitivity analysis for dichotomized UDPB (Universal Definition of Perioperative Bleeding) in all patients.
UDPB (Universal Definition of Perioperative Bleeding) as a measure of perioperative bleeding and dichotomized into UDPB 0-2 vs. UDPB 3-4 in all patients.
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.3
Sensitivity analysis for original five-grade UDPB (Universal Definition of Perioperative Bleeding) in all patients.
Five-grade UDPB (Universal Definition of Perioperative Bleeding) as a measure of perioperative bleeding in all patients.
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.Sponsors and contacts
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Source ClinicalTrials.gov
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