1-DEAMINO 8-D-ARGININA VASOPRESSIN IN PERCUTANEOUS ULTRASOUND-GUIDED RENAL BIOPSY: A RANDOMIZED CONTROLLED TRIAL - ND

• Conditions: Patients undergoing percutaneous ultrasound-guided biopsy of native kidney and at high risk of bleeding; MedDRA version: 9.1Level: SOCClassification code 10038359

• Registration Number: EUCTR2010-020722-18-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-10
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 80 years of age.
2) Blood pressure < 140/90mmHg.
3) Serum creatinine = 1.5mg/dl and/or creatinine clearance = 60ml/min.
4) Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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