None listed
Conditions
Interventions
Group A Type of group
150 mg of Plasmin in 75 ml
Group name:Group F Type of group
Blind placebo (0.9% NaCl for injection, USP or equivalent, not supplied): the volume should match the equivalent volume of BP according to the clinical criteria of the researcher
Sponsors
TALECRIS BIOTHERAPEUTICS, INC,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Unilateral limb ischemia: symptomatic. Categories I and IIa of Acute Ischemia SCV • onset of symptoms 10cm in length are eligible. • Diagnosis of thrombus with occlusion in the graft or artery by means of an arteriography after informed consent has been obtained • Ability to access the thrombus with the infusion catheter and successfully insert the infusion segment of the infusion catheter. • The subject must be able to sign their informed consent before participating in the study. • Age> 18 years • In the case of women of childbearing age, they must use an appropriate method of contraception during the study period and must have a negative pregnancy outcome before participating in the study.
Exclusion criteria
Exclusion criteria: • Any medical or social condition that may interfere with the completion of the study by the subject. • Pregnant or nursing women, or who are in the first 10 days of postpartum. • Cardiopulmonary resuscitation in the previous year • Previous systemic or anaphylactoid allergies to contrast agent, streptokinase or blood components (those allergic to shellfish or iodine may enter the study). • Not eligible for thrombolytic treatment for any reason • Active graft infection • Occlusion occurred within the first month of placement of the synthetic graft • Occlusion occurred within the first six months of autologous graft placement • A sequential mixed dual-exit graft to correct multiple occlusions • In the opinion of the Researcher, he is clinically unable to tolerate an open vascular procedure • History of prothrombotic state, such as anticardiopillin antibody, peripheral vascular disease associated with acquired immunodeficiency virus (HIV) • History of contraindication to heparin (eg, history of heparin-induced thrombocytopenia) • Hemoglobin 2.0 mg / dL in the baseline selection / evaluation. The creatinine test can be taken again after hydration by prerenal azotemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of subjects with a thrombolysis of 90%. Measure:Thrombolysis at the end of treatment compared to baseline evaluation Timepoints:90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Avoid major surgical revascularization, mechanical thrombectomy, and CDT with additional BP in the affected limb from the end of treatment until Day 30. Measure:Avoid major surgical revascularization, mechanical thrombectomy, and CDT with additional BP in the affected limb from the end of treatment until Day 30. Timepoints:90 days ; Outcome name:Blood flow in the native artery or graft under treatment, by ultrasound at the end of the treatment or post intervention and Day 30. Measure:Blood flow in the native artery or graft under treatment, by ultrasound at the end of the treatment or post intervention and Day 30. Timepoints:Day 30 ; Outcome name:Ischemic signs or symptoms of pain, paraesthesia, paralysis, poikilothermia, paleness and absence of pulse from baseline evaluation to the end of treatment Measure:Appearance of signs or symptoms Timepoints:During treatment | — |
Countries
Australia, Austria, France, Germany, Serbia, Slovakia, Spain, United Kindgdom
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed