Ionized Calcium and Bleeding in Cardiac Surgery

NCT07634042 | Not Yet Recruiting

• 1 other identifier: 04934
• Study Type: observational
• Target: 4,300
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Cardiac Surgery Subjects

Keywords

cardiac surgery; cardiopulmonary bypass; plasma ionized calcium; bleeding; perioperative bleeding

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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).

  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 (3)

• Time-weighted plasma ionized calcium concentration during the post-CPB phase in OR for both sensitivity analyses of all patients.

  The time interval between the cessation of CPB and the exit from OR.

• Sensitivity analysis for dichotomized UDPB (Universal Definition of Perioperative Bleeding) in all patients.

  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.

• Sensitivity analysis for original five-grade UDPB (Universal Definition of Perioperative Bleeding) in all patients.

  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.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital, Meilahti Hospital

Helsinki, 00029 HUS, Finland

Location

Related Publications (2)

• 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.

  PMID: 37120084 BACKGROUND

• Dyke 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.

  PMID: 24332097 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eero Juhani Pesonen, MD, PhD, docent

CONTACT

+358-40-5880781; eero.pesonen@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, docent

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)