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Sponsored by: |
University of Bari |
Information provided by: | University of Bari |
ClinicalTrials.gov Identifier: | NCT00748072 |
The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single centre, double blind, randomized controlled study in patients, with acute and chronic nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.
Condition | Intervention | Phase |
Kidney Failure |
Drug: DDAVP Drug: placebo |
Phase IV |
MedlinePlus related topics: | Kidney Failure Ultrasound |
Drug Information available for: | Sodium chloride Arginine Arginine hydrochloride Argipressin Vasopressins Desmopressin Desmopressin acetate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 1-Deamino 8-d-Arginine Vasopressin in Percutaneous Ultrasound-Guided Renal Biopsy: a Randomized Controlled Trial |
Estimated Enrollment: | 124 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator
treated with saline solution
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Drug: placebo
saline solution 4 ml subcutaneous
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2: Experimental
treated with DDAVP 1 hour before renal biopsy
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Drug: DDAVP
0.3 mcg/kg subcutaneous
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Renal biopsy is an essential procedure in the diagnosis of primary and secondary renal diseases. The technique has significantly improved over the past two decades because of the introduction of ultrasonography and automated-gun biopsy devices; however an accurate clinical, chemistry and renal ultrasound evaluation before and 24-hours post renal biopsy is necessary, because bleeding complications still occur in about 1/3 of our procedures, with major complications occurring in only 1.2% of patients. Of the data routinely collected for potential predictors of post-biopsy bleeding complications, only gender, age, and baseline partial thromboplastin time show a significant predictive value. The other variables investigated do not have any predictive value (Manno C et al, Kidney Int 2004). The majority of published studies, retrospective and non-randomized, on this topic have focused on the comparative performance of different renal biopsy techniques and types of needles, but no study has shown potential predictors of post-biopsy bleeding complications. On the other hand, the available studies have not shown any specific test to select patients with major risk of post-biopsy bleeding.
The aim of this study is to evaluate the effect of pre-biopsy treatment with DDAVP or desmopressin on the incidence of post-biopsy bleeding complications.
DDAVP is a synthetic derivative of the anti-diuretic hormone vasopressin; therefore, the administration of DDAVP is often accompanied by water retention, a drop in blood pressure and a secondary increase in heart rate. The haemostatic effect of DDAVP is related to an increase of vWF-factor VIII levels. DDAVP is the treatment of choice for most patients with von Willebrand (type I) disease and haemophilia A; moreover, the compound has been shown to be useful in a variety of inherited and acquired hemorrhagic conditions, including some congenital platelet function defects, chronic liver disease, uremia, and haemostatic defects induced by the therapeutic use of anti-thrombotic drugs such as aspirin and ticlopidine. Finally, DDAVP has been used as a haemostatic agent in patients undergoing surgery at major risk of bleeding. Disadvantages of DDAVP include reported rare thrombotic events.
Ages Eligible for Study: | 16 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carlo Manno, MD | +39 080-5478878 | c.manno@nephro.uniba.it |
Italy | |||||
Center and Atelier for Epidemiological Studies, University of Bari | Recruiting | ||||
Bari, Italy, 70124 |
University of Bari |
Principal Investigator: | Carlo Manno, MD | University of Bari |
Responsible Party: | Unit of Nephrology, University of Bari, Bari, Italy ( Carlo Manno, Assistant Professor Chair of Nephrology ) |
Study ID Numbers: | DDAVP 01 |
First Received: | September 5, 2008 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00748072 |
Health Authority: | Italy: Ministry of Health |
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