Systematic review of the efficacy and safety of fibrinogen concentrate substitution in adults.

BACKGROUND: A sufficient plasma level of fibrinogen is critical for the formation of a fibrin clot and haemostasis in both the perioperative setting and in massive haemorrhage. We assessed the efficacy and safety of fibrinogen concentrate substitution in the perioperative setting and in massive haemorrhage. METHODS: We conducted a systematic literature search for studies conducted on humans and published in either English or German in several databases from 1985 to 2010. In addition, we screened several web sites for assessments on fibrinogen concentrate substitution and conducted a hand search using Scopus. In terms of efficacy, we included all prospective, controlled studies. Concerning safety, we included all prospective studies. RESULTS: We identified two randomised controlled trials and two non-randomised controlled studies, which included a total of 74 patients. The studies indicate that the administration of fibrinogen concentrate is associated with improved clot firmness and reduction in the substitution of other blood products such as red blood cells, fresh frozen plasma and platelet concentrates, as well as decreased post-operative bleeding and drainage volume. In addition, fibrinogen concentrate administration has been reported to be safe with regard to thrombosis and thromboembolic complications, as well as mortality. However, the studies identified were of poor quality. CONCLUSION: In conclusion, the results of the available controlled trials suggest that the administration of fibrinogen concentrate was effective and safe. However, because all studies identified were of inadequate quality, these findings need to be confirmed by randomised controlled trials of sufficient size and long-term follow-up.

Human heart-type fatty-acid-binding protein as a point-of-care test in the early diagnosis of acute myocardial infarction.

BACKGROUND: At very early stages of acute myocardial infarction (AMI), highly sensitive biomarkers are still lacking. AIM: To evaluate the utility of human heart-type fatty acid-binding protein (h-FABP) for early diagnosis of AMI. DESIGN: Prospective diagnostic study. METHODS: Consecutive patients presenting to the emergency department with chest pain or dyspnoea within 24 h of symptom onset were included. At presentation, the h-FABP test result was compared to the standard diagnostic work-up, including repeated ECG and troponin T measurements. Sensitivity analysis was performed for inconclusive tests. RESULTS: We enrolled 280 patients presenting to hospital with a median symptom onset of 3 h (IQR 2-6 h): 109 (39%) had AMI. At presentation, h-FABP had a sensitivity of 69% (95%CI 59-77) and specificity of 74% (95%CI 66-80); 45 tests were false-positive and 34 were false-negative. Omitting inconclusive tests increased sensitivity and specificity only slightly. AMI was identified significantly earlier by h-FABP than by troponin T (24 vs. 8 patients, p=0.005). DISCUSSION: Although h-FABP can help to detect myocardial damage at an early stage in patients with chest pain or dyspnoea, it appears unsuitable as a stand-alone test for ruling out AMI.