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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of Enoxaparin in Intensive Care Patients

NCT02095509

Venous Thromboembolism

COMPLETED PHASE4

The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients.

NCT06795698

Fractures, Bone CKD Stage 4 CKD Stage 3 +4 more

COMPLETED PHASE2

Fondaparinux in Critically Ill Patients With Renal Failure

NCT01467583

Venous Thromboembolism

COMPLETED PHASE4

Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients

NCT02412982

Traumatic Injury Venous Thromboembolism

COMPLETED PHASE4

Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.

NCT04558892

Nephrotic Syndrome

TERMINATED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

enoxaparin

enoxaparin prophylaxis as directed by treating Intensivist

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No