Phase 4 Study Determining the Safety of Enoxaparin Prophylaxis in Critically Ill Adults With Severe Renal Insufficiency
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment
Study Overview
Brief 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.
Detailed 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:
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •body weight ≥ 45 kg
- •expected ICU length of stay ≥ 72 hours
- •severe renal insufficiency, defined by calculated creatinine clearance (CrCl) < 30 mL/min using the Cockcroft-Gault formula
- •All patients with severe renal insufficiency at ICU admission will be included, regardless of chronicity of renal disease. This includes patients with pre-existing dialysis dependence via intermittent hemodialysis and peritoneal dialysis; patients with acute kidney injury requiring SLED (sustained low-efficiency dialysis) will also be included.
Exclusion Criteria
- •neurological surgery in last 3 months
- •epidural catheter insertion within previous 12 hours
- •ICU admission > 2 weeks
- •receipt of > 2 doses of LMWH while in ICU or in hospital within 7 days prior to study enrolment
- •active bleeding; platelet count < 50 x 109/L
- •INR or aPTT > 2 times the upper limit of normal
- •need for therapeutic anticoagulation; previous adverse reaction to heparin based products
- •contraindication to blood product transfusion
- •pregnant or lactating women
- •life expectancy < 2 weeks or receiving palliative care
- •previous enrolment in current study.
Outcomes
Primary Outcomes
Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment
Time Frame: 24 months
This is a pilot feasibility study
Secondary Outcomes
- Record incidence of major bleeding episodes using the HEME bleeding assessment tool(Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less)
- Record incidence of VTE(Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less)
- Measure bioaccumulation of Enoxaparin, if any, defined as at least one trough anti-Xa level measuring > 0.4 IU/mL(ICU stay until discharge or a maximum of the first 10 days of ICU stay, whichever is less)