THERESA-4 Study

Phase 3

Not yet recruiting

• Conditions: Fluxion and thrombosed hemorrhoid.

• Registration Number: RPCEC00000122
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

1) Compliance with the diagnostic criteria (fluxion and / or thrombosed hemorrhoid anal pain characterized by sudden onset, with tumors of variable size and appearance and can be red-violet color, usually associated with significant swelling). 2) Age between 18 and 75 years inclusive. 3) Anal pain (of any degree of intensity) and / or bleeding at the time of inclusion in the study. 4) Voluntariness of the patient by signing the informed consent.

Exclusion Criteria

1) Background of intracranial hemorrhage. 2) History of cerebrovascular disease, intracranial surgery or head trauma <3 months. 3) Gastrointestinal bleeding or urinary tract <21 ??days. 4) Recent surgery <14 days. 5) Recent serious trauma <4 weeks. 6) Puncture of major vessels is not understandable in the last 7 days. 7) Treatment with anticoagulants. 8) Active internal bleeding (<3 weeks) or other conditions where there is risk of major bleeding, or would be difficult to handle because of their location. 9) Hemorrhoidal disease caused by portal hypertension. 10) Hemorrhoidal disease with septic complications, or associated with abscess, fistula or cancer. 11) Acute diarrheal disease in the last 12 hours. 12) Treatment with streptokinase in the preceding 6 months. 13) History of allergy to streptokinase, thiomersal, salicylates (including aspirin), corticosteroids, or any ingredient of the formulations under study. 14) Pregnancy or lactation at the time of inclusion in the study. 15) Mental incapacity to give consent clearly and act accordingly to the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified