Haemostatic drugs: a critical appraisal: a symposium ... organised at the University of Leuven on May 28-29th, 1976]

Clinical efficacy of haemostatic agents had to be published work and had to fulftl most of the following minimum requirements: (1) Quantitation ofthe measured blood loss was required, and not merely a clinical impression of the amount of blood lost, if the document pertained to a planned but {laquo}open{raquo} clinical trial. (2) Only double-blind trials with random allocation of the placebo and experimental drug to preselected patients were considered suitable for discussion, if the blood loss had not been quantitated in a prospective trial. (3) Defmition and appropriate selection of patients admitted to the trial: all inclusion and exclusion criteria used to select patients had to be mentioned in detail. (4) Once included in the trial, patients could be withdrawn only on the basis of strict criteria for withdrawal which had been defined in advance. (5) A double-blind trial had to be continued for an adequate length of time if the haemostatic agent was being assessed in the prevention of bleeding in patients with a long lasting bleeding disorder . (6) A clear and detailed statistical analysis of the results was required. Moreover, a clear distinction between the therapeutic and prophylactic value of the haemostatic agent had to be made and applied separately to the group of patients without any major basic disorder and those with a bleeding disorder e.g. : chronic thrombocytopenia, haemophilia, Rendu-Osler telangiectasia ... General statements not substantiated by experimental data, even when issued by well-known authorities, were not considered a reasonable basis for discussion Front Matter....Pages I-X The correction of a bleeding defect....Pages 1-7 Report on a tissue extract: Clauden®....Pages 8-10 Report on a preparation of phospholipids: Tachostyptan®....Pages 11-14 Comments by the manufacturer of Tachostyptan®....Pages 15-17 Report on a preparation of oxalic and malonic acids: Koagamin®....Pages 18-18 Report on a preparation of butyl alcohol: Haemostypticum Revici®....Pages 19-22 Report on sodium 4-aminonaphthalene-1-sulphonate: Naphthionin®....Pages 23-25 Report on ethamsylate....Pages 26-37 Comments by the manufacturer of Dicynene®....Pages 38-38 Report on aminaphtone....Pages 39-44 Comments by the manufacturer of Capillarema®....Pages 45-47 Report on a preparation of pectin: Sangostop®....Pages 48-53 Report on naftazone....Pages 54-57 Comments by the manufacturer of Karbinone®....Pages 58-58 Report on adrenochrome monosemicarbazide (carbazochrome) and carbazochrome salicylate....Pages 59-66 Comments on adrenochrome....Pages 67-67 Report on 5-hydroxytryptamine creatinine sulphate: Antemovis®....Pages 68-73 Report on a preparation of conjugated oestrogens: Premarin®....Pages 74-78 Comments by the manufacturer of Premarin®....Pages 79-81 Report on a preparation of oestriol succinate: Styptanon®....Pages 82-87 Comments by the manufacturer of Styptanon®....Pages 88-88 Report on a preparation of snake venom (from Bothrops jararaca): Botropase®....Pages 89-93 Comments on Botropase®....Pages 94-99 Report on a preparation of snake venom (from Bothrops atrox): Reptilase®....Pages 100-105 Comments by the manufacturer of Reptilase®....Pages 106-107 Report on aprotinin: Trasylol®....Pages 108-117 Report on epsilon aminocaproic acid (EACA) (6-aminohexanoic acid)....Pages 118-126 Report on p-aminomethyl-benzoic acid (PAMBA)....Pages 127-131 Report on tranexamic acid....Pages 132-139 Comments by the manufacturer of Cyklokapron®....Pages 140-141 Haemostatic agents for topical use....Pages 142-144 A note on vitamin C and bioflavonoids in bleeding disorders....Pages 145-146 The following recommendations are made for trials set up to determine the clinical usefulness of systemic haemostatic agents....Pages 147-151 Conclusions on the clinical efficiency of general haemostatic drugs....Pages 152-153 Back Matter....Pages 154-155