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NOT YET RECRUITING
NCT07634042

Ionized Calcium and Bleeding in Cardiac Surgery

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

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

Official title: Plasma Ionized Calcium and Perioperative Bleeding in Cardiac Surgery.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

4300

Start Date

2026-06-01

Completion Date

2029-12-31

Last Updated

2026-06-08

Healthy Volunteers

No

Locations (1)

Helsinki University Hospital, Meilahti Hospital

Helsinki, Finland