INFLAME STUDY

Study title

INFLAMmatory Injury of the Lung after Cardiac SurgEry

Rationale

TRALI is still one of the most feared complications of transfusion. Being rare however makes it hard to study the causal mechanisms of TRALI. A way out of this could be that, certain patient groups are known to often develop similar pulmonary injury after cardiac surgery leading to an increase in mortality of 25%. We hypothesize that the type and extent of ischemia reperfusion injury but additionally the inflammatory response due to the cardiopulmonary bypass (CPB) and the blood transfusions these patients receive will help us to understand how TRALI is induced also in other patients.

Study Objectives

It is our aim to correlate the occurrence and severity of acute lung injury (ALI) and ARDS in patients after cardiac surgery with clinical risk factors like age, gender, surgery- and CPB-time, and of course the extent and timing of transfusion support. The special focus however will be to measure markers of inflammation and ischemia reperfusion injury before during and after surgery and transfusions. Biomarkers that clearly precede and are correlated with, especially the pulmonary complications in these patients will show us which causal mechanisms are in play but might eventually also help us to design preventive measures. Complement activation, cytokine-levels, and systemic inflammation (monocyte-, neutrophil-, macrophage- and platelet activation) and endothelial injury will in this respect be monitored.

Study Design

The study is designed as a single centre prospective observational cohort study.

Study Population

All adult patients that are scheduled for any type of elective cardiac surgery with or without CPB (both complex heart failure surgery and low risk surgery)

Endpoints of the Study

Primary endpoints:

• Length of ICU-stay, length of hospital-stay, ICU-mortality, 30-day mortality in relation to inflammatory and other biomarkers

Secondary endpoints:

• Prognostic: occurrence of ALI and ARDS, duration of mechanical ventilation, in relation to biomarkers
• Etiologic: levels and time course of markers indicating mechanisms that can be intervened with.

Research Staff

MS Arbous MD PhD^1,2 (project leader)
J van Paassen MD¹ (investigator)
Prof JJ Zwaginga MD PhD^2,3,4  (project leader)

1. Department of Critical Care Medicine, Leiden University Medical Center, Leiden
2. Department of Clinical Epidemiology, Leiden University Medical Center, Leiden
3. Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands 
4. Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands