Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982055
• Other study ID #: IV vs SC LMWH ICU
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Clinique Saint Pierre Ottignies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients

Description:

The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients > 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated

Exclusion Criteria:

• renal failure determined by glomerular filtration rate (GFR) < 30 ml/min or need for renal replacement therapy

• liver cirrhosis

• intravascular disseminated coagulation

• contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,…)

• patients receiving low dose of vasopressor (norepinephrine < 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine = 0.25 mcg/kg/min)

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Nadroparin (intravenous Infusion)
Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU
• Nadroparin (subcutaneous group)
Subcutaneous route of administration of nadroparin 3800 IU

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint Pierre Ottignies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak anti-Xa activity	Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration	Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
Secondary	Trough anti-Xa activity	Trough anti-Xa activity measured 24 hours after start of low molecular weight administration	Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
Secondary	AUC (0-24h)	Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin	0-24 hours