Randomised controlled trial of prophylactic etamsylate: follow up at 2 years of age.
(1/12)
AIM: To assess the role of etamsylate in reducing the risk of haemorrhagic brain damage and its consequences. DESIGN: Follow up of babies recruited into a randomised controlled trial. METHODS: A total of 334 infants born before 33 weeks gestation in France and Greece were randomly allocated within the first four hours of birth either to receive etamsylate or to act as controls. The principal outcomes in the trial were death or impairment and/or disability at the age of 2 years. RESULTS: Fifty nine children were lost to follow up. A total of 115 (34%) either died or had some impairment or disability, and 88 (26%) either died or had severe impairment or disability at 2 years of age. These outcomes did not differ significantly between the two randomised groups: relative risks and 95% confidence intervals 1.14 (0.78 to 1.4) and 1.17 (0.82 to 1.68) respectively. The findings were similar for all the prespecified subgroup analyses stratified by key prognostic factors at trial entry: country of birth, gestational age < or >or= 29 weeks, inborn or outborn, age < or >or= 1 hour, and with or without cerebral scan abnormality. CONCLUSION: These findings do not support the use of etamsylate. Other strategies need to be evaluated for the prevention of mortality and morbidity in these vulnerable infants. (+info)
Developmental outcome of the use of etamsylate for prevention of periventricular haemorrhage in a randomised controlled trial.
(2/12)
OBJECTIVE: To compare neurodevelopmental outcome of survivors of the multicentre trial of etamsylate (the iRNN for ethamsylate) for prevention of periventricular haemorrhage in very low birthweight infants. DESIGN: Double blind, single observer, prospective follow up of placebo controlled study. SETTING: Six neonatal intensive care units in the United Kingdom. Neurodevelopmental outcome was assessed in health premises or children's homes. SUBJECTS: 268 of 276 survivors of the original study were seen between 3.5 and 4.2 years of age. All were inborn and weighed 1500 g or less at birth. INTERVENTION: Etamsylate 12.5 mg/kg or placebo six hourly from within one hour of delivery for four days. MAIN OUTCOME MEASURES: McCarthy scales of children's abilities, standardised neurological examination, full physical examination, functional assessment, seven letter Stycar vision test, and audiometry. RESULTS: There was no difference between the groups in neuromotor outcome (cerebral palsy) or in the general cognitive index (GCI) of the McCarthy scales (mean GCI was 93.3 for the etamsylate group (n = 133) and 89.7 for the placebo group (n = 131); p = 0.10). There were more children with GCI < 70 (9 v 19; p = 0.047) or +info)
Minimising neonatal brain injury: how research in the past five years has changed my clinical practice.
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With improving neonatal survival for extremely premature babies, the challenge for neonatology is to improve outcome of surviving babies. This review concentrates on best evidence emerging in recent years on prevention of brain damage by early administration of drugs as well as avoidance of induced brain damage by hyperventilation and dexamethasone therapy given postnatally for chronic lung disease. (+info)
Application and equivalence assessment for determining ethamsylate by using potassium ferricyanide as spectroscopic probe reagent.
(4/12)
In this paper, a novel method has been established to determine ethamsylate using potassium ferricyanide as a spectroscopic probe reagent. It has been demonstrated that Fe(III) is reduced to Fe(II) by ethamsylate, and that the formed Fe(II) reacts with potassium ferricyanide to form soluble prussian blue (KFe(III)[Fe(II)(CN)(6)]). Beer's law is obeyed in the range of 0.16 - 24.00 microg mL(-1) with the molar absorption coefficient of 2.1 x 10(4) L mol(-1) cm(-1). The detection limit (3 sigma/k) is 0.11 microg mL(-1). This method has been successfully applied to determine ethamsylate in pharmaceutical and serum samples with satisfactory results, and presented quite satisfactory credibility during method equivalence assessment. (+info)
Short-term efficacy of intravitreal dobesilate in central serous chorioretinopathy.
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Effects of ethamsylate on cerebral blood flow velocity in premature babies.
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Cerebral blood flow velocity and cardiac output were measured with ultrasound before and 30 minutes after the administration of ethamsylate in a double blind placebo controlled study of 19 very low birthweight infants. No differences were found before or after treatment in either group. (+info)
Failure of ethamsylate to reduce aspirin-induced gastric mucosal bleeding in humans.
(7/12)
1. We investigated the effect of the haemostatic agent ethamsylate on aspirin-induced gastric mucosal bleeding. 2. Eighteen healthy subjects were studied three times: at the end of 48 h periods of treatment with (a) placebo, (b) aspirin 600 mg four times daily, (9 doses) and (c) aspirin 600 mg four times daily with each dose preceded by ethamsylate 500 mg. 3. At the end of each treatment period gastric mucosal bleeding into timed gastric washings was quantified using the orthotolidine reaction. 4. Aspirin increased bleeding from a rate on placebo of 1.2 microliters 10 min-1 geometric mean (95% confidence limits) (0.7-1.8) microliters 10 min-1 to 20.0 (11.6-34.2) microliters 10 min-1, (P less than 0.01). The rate of bleeding after aspirin preceded by ethamsylate [14.1 (8.5-23.4) microliters 10 min-1] was not significantly different from that after aspirin alone. 5. We conclude that ethamsylate does not reduce acute aspirin-induced gastric mucosal bleeding in healthy humans. (+info)
Ethamsylate in vaginal surgery under lumbar epidural anaesthesia.
(8/12)
Sixty patients scheduled for vaginal surgery under lumbar epidural block were randomly allocated into two groups, one of which received ethamsylate intravenously prior to induction of anaesthesia. Ethamsylate did not reduce the blood loss at operation in these patients. The possible factors underlying this observation are discussed. (+info)