Patients undergoing percutaneous ultrasound-guided biopsy of native kidney and at high risk of bleeding MedDRA version: 9.1 Level: SOC Classification code 10038359
Conditions
Interventions
Trade Name: EMOSINT
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Desmopressin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To evaluate the effect of pre-biopsy treatment with DDAVP on the incidence of post-biopsy bleeding complications Patients at high risk of bleeding: 1) Males or females > 16 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Biopsy of transplant kidney 2) Poorly controlled hypertension 3) Single kidney 4) Renal cancer 5) Hydro/pyonephrosis 6) Renal size significantly reduced 7) Severe obesity 8) Coagulation disorder 9) Serum creatinine > 1.5mg/dl and/or creatinine clearance < 60ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the haemostatic efficacy of pre-biopsy treatment with DDAVP on the incidence of post-biopsy bleeding.;Secondary Objective: To evaluate the haemostatic efficacy of pre-biopsy treatment with DDAVP on the incidence of post-biopsy bleeding;Primary end point(s): To evaluate the effect of pre-biopsy treatment with DDAVP on the incidence of post-biopsy bleeding complications | — |
Countries
Italy
Outcome results
None listed