Haemostatic Drugs

1. Front Matter

   Pages I-X

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2. The correction of a bleeding defect

   • M. Verstraete

   Pages 1-7

3. Report on a tissue extract: Clauden®

   • M. Verstraete

   Pages 8-10

4. Report on a preparation of phospholipids: Tachostyptan®

   • M. Verstraete

   Pages 11-14

5. Comments by the manufacturer of Tachostyptan®

   • F. Schulte

   Pages 15-17

6. Report on a preparation of oxalic and malonic acids: Koagamin®

   • M. Verstraete

   Pages 18-18

7. Report on a preparation of butyl alcohol: Haemostypticum Revici®

   • M. Verstraete

   Pages 19-22

8. Report on sodium 4-aminonaphthalene-1-sulphonate: Naphthionin®

   • M. Verstraete

   Pages 23-25

9. Report on ethamsylate

   • M. Verstraete

   Pages 26-37

10. Comments by the manufacturer of Dicynene®

    • J. V. Reed

    Pages 38-38

11. Report on aminaphtone

    • M. Verstraete

    Pages 39-44

12. Comments by the manufacturer of Capillarema®

    • U. Baldacci

    Pages 45-47

13. Report on a preparation of pectin: Sangostop®

    • M. Verstraete

    Pages 48-53

14. Report on naftazone

    • M. Verstraete

    Pages 54-57

15. Comments by the manufacturer of Karbinone®

    • G. Derouaux

    Pages 58-58

16. Report on adrenochrome monosemicarbazide (carbazochrome) and carbazochrome salicylate

    • M. Verstraete

    Pages 59-66

17. Comments on adrenochrome

    • G. Derouaux

    Pages 67-67

18. Report on 5-hydroxytryptamine creatinine sulphate: Antemovis®

    • M. Verstraete

    Pages 68-73

19. Report on a preparation of conjugated oestrogens: Premarin®

    • M. Verstraete

    Pages 74-78

20. Comments by the manufacturer of Premarin®

    • M. Gahwyler

    Pages 79-81

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 «open» 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.

• alcohol
• blood
• clinical trial
• drug
• drugs
• patients
• prevention
• tissue

• Department of Medical Research, University of Leuven, Belgium

  M. Verstraete

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