Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT02622906
Eligibility Criteria:
Inclusion Criteria:
1. Angiodysplasia of the stomach, small intestine or colon confirmed by endoscopy.
2. 6 or more of packed red cells unit transfusion during the 6 months prior inclusion.
3. Failed endoscopic therapy or cons-indication for endoscopic treatment.
4. Patient affiliated to a social security insurance.
5. Age \> 18 years.
6. Consent signed by the patient.
Exclusion Criteria:
1. Treatment with somatostatin analogue in the 6 months prior to inclusion
2. Symptomatic cholelithiasis
3. Rendu-Osler disease
4. Uncontrolled diabetes (HbA1c \> 8%)
5. Breaking of the esophageal varicose veins bleeding older than six months.
6. Patients treated with anti vitamin K at baseline and during the study.
7. Patients with (AST, ALT\> 2 ULN) and / or total bilirubin \> 1.5 ULN.
8. TP \< 50%, platelets \<75 000/mm3, aPTT\> 1.5 times the control
9. Uncontrolled heart disease: myocardial infarction within 6 months, status epilepticus angina, congestive heart failure grade III and NYHA, ventricular tachycardia, ventricular fibrillation, heart block, severe
10. Family medical history of the idiopathic sudden death
11. Syncope like medical history
12. QTcF\> 450 ms
13. Metastatic malignancy
14. Pregnant or nursing women, women of childbearing age who have not achieved pregnancy test, women and men of reproductive age without effective contraception
15. Impossible follow for psychological and/or geographical reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02622906
Study Brief:
Protocol Section:
NCT02622906