Lack of human-relevant adversity of MOSH retained in tissues: Analysis of adversity and implications for regulatory assessment.

Mineral oils (food grade white oil or liquid paraffin) have historically been safely used in a number of sensitive end-uses, including pharmaceutical, cosmetic and food. Recent concern that certain mineral hydrocarbons (branched and cyclo-alkanes) may accumulate in human tissues has prevented European Food Safety Authority (EFSA) from deriving guidance values for food exposures. Analysis of human and animal tissue indicate that an unresolved cloud of mostly highly branched alkanes and alkylated cycloalkanes within the C20-C35 range is consistently present in all tissues. This critical review thoroughly assesses the retention of "mineral oil saturated hydrocarbons" (MOSH) in human and animal tissues and evaluates if the presence of MOSH is considered adverse and appropriate to use for risk assessment, generation of guidance values for food exposure and/or generation of derivation of health-based guidance values. An adversity framework was utilized to perform an in-depth weight of the evidence analysis, and it was concluded that mere presence of MOSH does not translate to hazard identification, and is not considered adverse. In light of this conclusion, it would not be appropriate to utilize this endpoint as the point of departure to calculate a health guidance value.

Evaluation of the in-hospital Utstein template in cardiopulmonary resuscitation in secondary hospitals.

INTRODUCTION: The in-hospital Utstein template for cardiopulmonary resuscitation (CPR) was assessed in four secondary hospitals (334-441 beds) which did not have systematic data collection. MATERIALS AND METHODS: The reports and outcome over a period of 12 months during the years 2000-2001 were evaluated. RESULTS: Of a total of 1690 patients that had a cardiac arrest (CA), 204 (12%) were resuscitated. Information on the collected Utstein parameters were available as follows: initial rhythm in 91%, time interval from collapse to defibrillation (in case of ventricular fibrillation or ventricular tachycardia as initial rhythm) in 90%, time interval to return of spontaneous circulation (ROSC) in 83% and duration of resuscitation in 83%. ROSC was achieved in 69 patients (34%, CI 27-41%) and 34 (17%, CI 11-23%) survived to hospital discharge. Twenty patients showed satisfactory neurological recovery (10%, CI 6-14%). Eighteen (9%, CI 5-13%) patients were alive at 12 months from the event. Factors associated with survival to hospital discharge were VF/VT (P=0.007) as the initial rhythm and shorter interval to defibrillation (P=0.046). CONCLUSION: The in-hospital Utstein template was logical but laborious and it provided tools for resuscitation management evaluation in the study hospitals. For continuous use, a slightly compressed model may be warranted. In the present material, the overall survival rate to hospital discharge was in line with previous reports but there were somewhat less neurologically satisfactory survivors. There is an evident need to improve the outcome of patients suffering CA on the wards. An important step is to reduce the time interval to defibrillation.

Treatment of hypothermic circulatory arrest with thoracotomy and pleural lavage.

We describe a successful case of severe hypothermia due to coldwater immersion. An eight-year-old boy was saved from cold water (4 degrees C) after forty minutes. Open rewarming and resuscitation was performed by thoracotomy and pleural lavage for cardiac arrest due to the low core temperature (25 degrees C). The patient recovered primarily well without any postoperative complications. The follow-up of two years shows good state of physical health but some neuropsychological defects disturbing normal progress in school work.

Tranexamic acid (Cyklokapron) reduces perioperative blood loss associated with total knee arthroplasty.

In this prospective, randomized, double-blind study, we have investigated the effect of an antifibrinolytic agent, tranexamic acid (Cyklokapron), on blood loss and transfusion requirements associated with total knee arthroplasty. Twenty-nine patients were allocated randomly to receive either tranexamic acid 15 mg kg-1 or an equal volume of placebo a few minutes before a tourniquet was deflated. Blood loss during surgery, in the recovery room and on the surgical ward was recorded, together with the number of units of blood transfused in hospital. Mean blood loss during surgery was 428 (SD 254) ml in the tranexamic acid group (n = 15) compared with 415 (244) ml in the placebo group (n = 13). In the recovery room the tranexamic acid group lost 127 (95) ml and the placebo group 576 (245) ml (P < 0.001). On the ward the respective volumes were 293 (200) ml and 558 (293) ml (P < 0.01). Total blood loss was 847 (356) ml in the tranexamic acid group and 1549 (574) ml in the placebo group (P < 0.001). During the hospital stay the treatment group received 1.5 (1.3) units of blood compared with 3.3 (1.8) in the control group (P < 0.005). Two patients in the placebo group experienced a thrombotic complication compared with none in the treatment group. We conclude that tranexamic acid reduced perioperative blood loss and transfusion requirements associated with total knee arthroplasty.

Tranexamic acid radically decreases blood loss and transfusions associated with total knee arthroplasty.

The application of a pneumatic tourniquet in orthopedic procedures enhances local fibrinolysis. Consequently, a short-term antifibrinolytic therapy may be indicated in this clinical situation to reduce postoperative blood loss. The purpose of this prospective double-blind study was to investigate the effect of tranexamic acid (TA) on blood loss associated with total knee arthroplasty (TKA). Seventy-five patients scheduled for 77 TKAs were randomized to receive either TA (n = 39) or equal volume of normal saline (NS, n = 38). Before deflation of the tourniquet, 15 mg/kg of TA was given intravenously followed by two 10-mg/kg additional doses. Perioperative blood loss gathered in surgical gauzes, suction reservoirs, and postoperative drainage system was measured. The number of transfusions given during hospitalization was registered. Total blood loss (mean +/- SD) was 689 +/- 289 mL in the TA group and 1509 +/- 643 mL in the NS group (P < 0.0001). The mean number of transfused red cell units in the TA group was 1.0 +/- 1.2 compared to 3.1 +/- 1.6 in the NS group (P < 0.0001). Twenty-two patients in the TA group and four patients in the NS group were treated without transfusion (P < 0.00003). Two patients in the TA group and three in the NS group had a deep venous thrombosis, including a fatal case of pulmonary embolism in the NS group. We conclude that short-term TA therapy significantly reduces TKA-associated blood loss and transfusion requirements without increasing thromboembolic complications.