THERESA-4 Study

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

Primary Outcome Measures

Name	Time	Method
- Clinical response after initiation of treatment (complete response [no anal pain, rectal bleeding and no reduction of 70% or more of the initial size of the lesion hemorrhoidal] Partial Response [presence of pain and / or rectal bleeding but with reduced level of intensity, and hemorrhoidal lesion reduction of 50-69%]; no Response [no reduction in pain intensity and / or rectal bleeding, and reduction of less than 50% of the lesion hemorrhoidal]) . Measuring time: 3, 5, and 10 days post-treatment. - Cessation of pain and anal bleeding (Yes, No). Measuring time: 3, 5, and 10 days post-treatment.

Secondary Outcome Measures

Name	Time	Method
- Termination of the other clinical manifestations (edema, pruritus, sensation of a mass, tenesmus, constipation, anal burning and diarrhea, among others) (Yes, No). Measuring Time: 72 hours, the 5th and 10th days post-treatment. - Need for thrombectomy (Yes, No). Measuring time: during the implementation period of the trial. - Adverse events (number of events, type, frequency: Yes, No, Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related adverse event; Duration: hours, days Causation: remote, possible, likely, very likely; Result: Completely resolved, Resolved with sequelae, conditions improved, still present and unchanged conditions, worsening, Death, treatment indicated: type and dosage of medication, treatment time). Measurement time: 72 hours, the 5th and 10th days post-treatment.