THERESA

Phase 1

• Conditions: Acute Haemorrhoidal Disease.; Gastrointestinal Diseases; Hemorrhoids; Rectal Diseases; Intestinal Diseases; Digestive System Diseases; Vascular Diseases

• Registration Number: RPCEC00000021
• Lead Sponsor: Genetic and Biotechnological Engineering Center (CIGB), of Havana.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

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

1. Antecedents of intracranial haemorrhage. 2.Antecedents of cerebrovascular illness, intracranial surgery or cranial trauma < 3 months. 3.Digestive or urinary bleeding < 21 days. 4.Recent surgery < 14 days. 5.Recent serious traumatism < 4 weeks. 6.Puncture of not compressible major vases in the last 7 days. 7.Trombine time > 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.