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Ionized Calcium and Bleeding in Cardiac Surgery

3 de junio de 2026 actualizado por: Eero Pesonen, Helsinki University Central Hospital

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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

4300

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Eero Juhani Pesonen, MD, PhD, docent
  • Número de teléfono: +358-40-5880781
  • Correo electrónico: eero.pesonen@hus.fi

Ubicaciones de estudio

  • Finlandia
      • Helsinki, Finlandia, 00029 HUS
        • Helsinki University Hospital, Meilahti Hospital
        • Contacto:
          • Eero Pesonen, MD, PhD, docent
          • Número de teléfono: +358-40-5880781
          • Correo electrónico: eero.pesonen@hus.fi
        • Investigador principal:
          • Eero Pesonen, MD, PhD, docent
        • Sub-Investigador:
          • Minna Ilmakunnas, MD, PhD, docent
        • Sub-Investigador:
          • Peter Raivio, MD, PhD, docent
        • Sub-Investigador:
          • Erika Wilkman, MD, PhD, docent
        • Sub-Investigador:
          • Liisa Petäjä, MD, PhD
        • Sub-Investigador:
          • Lotta Joenpolvi, medical student

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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).

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time-weighted plasma ionized calcium concentration during the post-CPB phase in OR for the primary and secondary analyses.
Periodo de tiempo: 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.
The time interval between the cessation of CPB and the exit from OR.
Dichotomized UDPB (Universal Definition of Perioperative Bleeding).
Periodo de tiempo: 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.
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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Original five-grade UDPB (Universal Definition of Perioperative Bleeding).
Periodo de tiempo: 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.
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.
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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Time-weighted plasma ionized calcium concentration during the post-CPB phase in OR for both sensitivity analyses of all patients.
Periodo de tiempo: 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 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.
Periodo de tiempo: 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 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.
Periodo de tiempo: 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.
Five-grade UDPB (Universal Definition of Perioperative Bleeding) as a measure 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Helsinki University Central Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

28 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 04934

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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