Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention

NCT04520620 | Withdrawn Phase 4

• 2 other identifiers: 20CH0892020-001823-15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

Patients with COVID-19 have special demographic characteristics including thromboembolic risk factors . The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit patient are not described. Finally, given the lack of knowledge on the pharmacokinetic/pharmacodynamic properties of enoxaparin in intensive care unit patients infected with SARS-CoV-2, we propose to conduct a prospective multicenter cohort study to collect the biological data necessary for its study.

Conditions

Sars-CoV2

Keywords

enoxaparin; intensive care unit; pharmacokinetics; SARS-Co-V-2; Lovenox

Outcome Measures

Primary Outcomes (1)

• Measure of anti-Xa activity

  Measure of anti-Xa activity by chromogenic method.

  Up to 1 month

Secondary Outcomes (6)

• Analysis of hemorrhagic risk

  Up to 1 month

• Venous thromboembolic events

  Up to 1 month

• Analysis individual patient characteristics by the biomarker of Kidney function

  Up to 1 month

• Analysis individual patient characteristics by the biomarker of inflammation

  Up to 1 month

• Analysis individual patient characteristics by the biomarker of coagulation

  Up to 1 month

Study Arms (1)

enoxaparin treatment

EXPERIMENTAL

Patients infected by SARS-CoV-2 in intensive care unit with enoxaparin treatment will be included. They will have enoxaparin pharmacokinetic and ultrasound of the lower limbs at 7, 14 and 21 days after inclusion.

Drug: Lovenox 40 MG in 0.4 mL Prefilled Syringe; Device: Ultrasound of the lower limbs

Interventions

Lovenox 40 MG in 0.4 mL Prefilled Syringe DRUG

Patients with a high thrombotic risk: In patients with a BMI included between \< 30 kg/m² and \> 30 kg/m² without added thrombotic risk factor: * Enoxaparin 40 milligrams, (4,000 IU) twice daily subcutaneously (SC) for the entire duration of the intensive care hospitalization * if weight \> 120 kg, enoxaparin 60 milligrams (6000 IU) twice daily subcutaneously for the entire duration of the intensive care hospitalization Patients with a very high thrombotic risk: In patients with a BMI \> 30 kg/m2 with added thrombotic risk factor (active cancer, recent personal history of thromboembolic event), or if iterative or unusual catheter thromboses, or if marked inflammatory syndrome and/or hypercoagulability (e.g. fibrinogen \> 8 g/L or D-Dimer \> 3 μg/ml or 3000 ng/ml) \* Enoxaparin sodium curative at a dose of 100 IU/kg/12h subcutaneously (SC) not to exceed a dose of 100 mg/12 hours

Also known as: enoxaparin

enoxaparin treatment

Ultrasound of the lower limbs DEVICE

A 4-point compression ultrasound will be performed. In case of suspicion, an angiologist will perform to check the absence of legs thrombosis.

enoxaparin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \> 18 ans
• SARS-CoV-2 infected intensive care unit patients
• Diagnosis of SARS-CoV-2 respiratory infection was made with a nasopharyngeal swab or a deep respiratory specimen.
• Patient receiving enoxaparin treatment as part of care or as part of a clinical trial for the prevention or treatment of thromboembolic venous disease.
• Patient affiliated or entitled to a social security scheme

You may not qualify if:

• Creatinine clearance according to Cockcroft and Gault \<30ml/min.
• Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWHs)
• History of immune-mediated heparin-induced thrombocytopenia (HIT) in the last 100 days or in the presence of circulating antibodies
• Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmologic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm or major intrarachidian or intracerebral vascular abnormalities.
• Spinal, epidural or locoregional anaesthesia or anaesthesia when enoxaparin sodium is used for curative treatment within the previous 24 hours

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang: collaborator

Study Sites (4)

Groupement Hospitalier des portes de Province

Montélimar, France

Location

Centre Hospitalier de Roanne

Roanne, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

Clinique Mutualiste

Saint-Etienne, France

Location

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Paul ZUFFEREY, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 20, 2020
• Study Start: May 2, 2020
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)