Safety Study of Enoxaparin Prophylaxis in Critically Ill Adults With Severe Renal Insufficiency

Hemorrhage Clinical Trial

Official title: Phase 4 Study Determining the Safety of Enoxaparin Prophylaxis in Critically Ill Adults With Severe Renal Insufficiency

Status Recruiting

Clinical Trial Summary

The investigators study is the first step (a pilot study) in determining whether the manufacturer's recommended dose of a blood thinner called enoxaparin, in adults who are patients in an intensive care unit and have severely reduced kidney function (less than or equal to approximately 30% of their normal function) is safe with respect to the adverse effect of bleeding.

The investigators hypothesis is that studying these patients, going forward in time, without interfering with their care, to eventually determine if this blood thinner is safe at reduced doses, is feasible.

Clinical Trial Description

Objectives:

To determine the feasibility of conducting a single centre, open-label, prospective study to inform preparation for a prospective phase III study evaluating the efficacy & safety of enoxaparin prophylaxis in critically ill adults with creatinine clearance < 30 mL/min.

Study Design:

A pilot open-label, single-arm, prospective study.

Patients:

Critically ill adults (> 18 years) with creatinine clearance < 30 mL/min.

Setting:

The Ottawa Hospital Intensive Care Units

Sample Size: n=30.

Intervention:

Study patients will receive enoxaparin 30 mg S.C. daily for VTE prophylaxis as directed by their responsible Intensivist. The investigators are not directing this clinical intervention in any manner.

Primary/Feasibility Outcomes: screening and enrolment rates with a goal of recruiting at least 5 patients collectively, from both ICUs, per month.

Secondary/Clinical Outcomes: Determining the accumulation of anti-Xa concentrations, if any, recording of the rates of major bleeding, VTE, and HIT during the study.

Trial Duration:

Anticipated 24 months.

Analysis:

Statistical analysis will be performed using SAS software through the Ottawa Hospital Methods Centre. Patient demographics and clinical baseline characteristics will be described. Continuous variables will be presented as mean (SD), ordinal variables as medians (IQR) and categorical variables as proportions. Cox proportional hazards analysis will be used to evaluate an association between trough anti-Xa levels and major bleeding. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Hemorrhage
• Renal Insufficiency

• NCT number: NCT02690090
• Study type: Observational
• Source: Ottawa Hospital Research Institute
• Contact: Rakesh V Patel, M.D.
• Phone: 613.737.8899
• Email: rpatel@toh.on.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2014
• Completion date: December 2016