Comparison of Blood and Crystalloid Cardioplegia
The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min. Adult patients with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study. This group of patients was chosen for two reasons. First, these patients have left ventricular hypertrophy making the myocardium vulnerable to ischemia, secondly the investigators wanted to avoid the possible confounding effect of ischemia found in patients with variable degrees of coronary artery disease. Therefore, patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||4 Days|
|Official Title:||Comparison of Blood and Crystalloid Cardioplegia on Patients Operated With Significant Aortic Stenosis. A Prospective Randomized Study.|
- CK-MB, troponin-T [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- cytokines under ischemia. [ Time Frame: 70 min ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||September 2012|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
1 Blood cardioplegia
2 Crytalloid Cardioplegia
Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.
Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941420
|Thoraxkirurgisk avdeling UUS|
|Study Director:||Theis Tönnessen, prof.Dr.Med||Thoraxkirurgisk avdeling UUS|
|Study Chair:||Björn Braathen, med.doc||Thoraxkirurgisk avdeling UUS|