ABSTRACT
OBJECTIVES: Specifically we aim to demonstrate that the results of our earlier safety data hold true in this much larger multi-national and multi-ethnical population. BACKGROUND: We sought to re-evaluate the frequency, manifestations, and severity of acute adverse reactions associated with administration of several gadolinium- based contrast agents during routine CMR on a European level. METHODS: Multi-centre, multi-national, and multi-ethnical registry with consecutive enrolment of patients in 57 European centres. RESULTS: During the current observation 37,788 doses of Gadolinium based contrast agent were administered to 37,788 patients. The mean dose was 24.7 ml (range 5-80 ml), which is equivalent to 0.123 mmol/kg (range 0.01 - 0.3 mmol/kg). Forty-five acute adverse reactions due to contrast administration occurred (0.12%). Most reactions were classified as mild (43 of 45) according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (15 of 45), followed by nausea (10 of 45) and flushes (10 of 45). The event rate ranged from 0.05% (linear non-ionic agent gadodiamide) to 0.42% (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR ranging from 0.05% (risk stratification in suspected CAD) to 0.22% (viability in known CAD). CONCLUSIONS: The current data indicate that the results of the earlier safety data hold true in this much larger multi-national and multi-ethnical population. Thus, the "off-label" use of Gadolinium based contrast in cardiovascular MR should be regarded as safe concerning the frequency, manifestation and severity of acute events.
Subject(s)
Adverse Drug Reaction Reporting Systems , Cardiovascular Diseases/diagnosis , Contrast Media/adverse effects , Drug-Related Side Effects and Adverse Reactions/ethnology , Gadolinium/adverse effects , Magnetic Resonance Imaging/adverse effects , Acute Disease , Dose-Response Relationship, Drug , Drug-Related Side Effects and Adverse Reactions/diagnosis , Europe/epidemiology , Humans , Patient Safety , Registries , Risk Assessment , Risk Factors , Severity of Illness IndexABSTRACT
Fibrin-fibrinogen degradation products and SP 1 were measured in about 150 women with normal pregnancies. The mean levels of both parameters rose up to term. In 13 normal pregnancies the SP 1 course never decreased. Elevated levels of SP 1 were measured in 4 out of 10 cases of mild gestosis. In 11 cases of severe gestosis, however, 7 had increased values. A decrease of elevated levels correlated to a clinical deterioration. SP 1 was normal in the most cases of severe gestosis, but a fall of SP 1 indicated an impaired placental function resulting in small-for-date baby or imminent foetal asphyxia. The measurements of fibrinogen degradation products and of the course of SP 1 are helpful in the diagnosis of gestosis.
