Clinical trial NCT03158792: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
Official title: Evaluation of Non-Surgical Venous Thromboembolism Prophylaxis Dosing Strategies: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thromboembolism
Renal Impairment
Keywords: Anticoagulation
Thromboprophylaxis
Anti-Xa levels
Elderly
Prevention
Enoxaparin
Low molecular weight heparin
Lead sponsor: Lebanese American University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 32
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.


Eligibility criteria: Inclusion Criteria:

* Non-surgical patients
* 70 years of age or older
* With renal impairment (creatinine clearance ≤35ml/min)
* Requiring pharmacological thromboprophylaxis

Exclusion Criteria:

* Indication for a treatment dose of anticoagulant treatment
* Knee surgery or hip surgery within 10 to 35 days, respectively
* Surgery, trauma, hemodialysis, peritoneal dialysis, or bleeding
* History of heparin-induced thrombocytopenia
* Known or suspected hypersensitivity to any component of study drug
* Patients with an excessive risk of bleeding and not eligible for pharmacological thromboprophylaxis based on physician assessment or due to any of the 3 major risk factors including active gastroduodenal ulcer, bleeding within the past three months prior to hospital admission, or a platelet count of \<50,000 platelets/ mm3

Primary outcomes:
measure: Peak anti-Xa levels
timeFrame: Day 3 of thromboprophylaxis
Secondary outcomes:
measure: Trough anti-xa levels
timeFrame: Day 3 of thromboprophylaxis
measure: Bleeding according to the GUSTO bleeding criteria.
timeFrame: Bleeding within 30 days will be assessed from randomization till date of bleeding or date of discharge, whichever comes first.
measure: Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE) including both deep vein thrombosis (DVT) and or pulmonary embolism (PE).
timeFrame: Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: LAU Medical Center-Rizk Hospital
Study officials:
affiliation: Lebanese American University
name: Nibal R Chamoun, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chamoun N, Ghanem H, Hachem A, Hariri E, Lteif C, Mansour H, Dimassi H, Zalloum R, Ghanem G. Evaluation of prophylactic dosages of Enoxaparin in non-surgical elderly patients with renal impairment. BMC Pharmacol Toxicol. 2019 May 7;20(1):27. doi: 10.1186/s40360-019-0308-8.