Acute Haemorrhoidal Disease.
Conditions
Interventions
Administration of 4 suppositories of 200 000 IU of SK distributed each 6 hours.
Sponsors
Genetic and Biotechnological Engineering Center (CIGB), of Havana.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Diagnostics of the acute haemorrhoidal illness. 2.Age equal or superior to 18 years. 3.Voluntariety of the individual by jeans of the signature of the written consent. Patients of both sexes were included.
Exclusion criteria
Exclusion criteria: 1. Antecedents of intracranial haemorrhage. 2.Antecedents of cerebrovascular illness, intracranial surgery or cranial trauma 20 seconds or a coagulation time > 10 seconds. 8.Treatment with anticoagulant pharmaceutical products. 9.Active internal haemorrhage (<3 weeks) or other conditions where there’s important bleeding risk or it’ll be difficult to handle ought to its location. 10.Haemorrhoidal illness caused by portal hypertension. 11.Haemorrhoidal illness associated to abscesses, fistula or cancer. 12.Haemorrhoidal illness with septic or active hemorrhagic complications. 13.Administration of streptokinase in the precedent 6 months. 14.Antecedents of allergy to streptokinase or salicylates including aspirin. 15.Pregnancy or lactation. 16.Evident mental incapacity to emit the consent and act consequently with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation: 1.Adverse clinical events (type, duration, seriousness, result and causality relation) by means of interrogation, and general and local physical examination. Measurement time: 24 hours, 48 hours and at 10 days post-leaving. 2.Haemostasis: Haemostatic parameters (thrombin time, fibrinogen and degradation products of fibrin/fibrinogen -PDF). Measurement time: 24 and 48 hours. 3.Immunogenicity: Presence of anti-streptokinase antibodies. Measurement time: 10 days from leaving. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Pain: measured by a visual analogous scale. 2.Œdema: evaluated by its presence or not at the direct physical examination (inspection) of the region. 3.Lesion size: indirect and objective measure of the oedema evolution. The patient was placed in decubitus prone with exposure of the anal part and measured in centimetres, at the beginning, 24 and 48 hours, the larger horizontal and vertical diameters of the lesion. | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez-Bernal
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Outcome results
None listed