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

Sponsor

Clinique Saint Pierre Ottignies (Other)

Overall Status

Completed

CT.gov ID

NCT04982055

Collaborator

(none)

Enrollment

Arms

68.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Drug: Nadroparin (intravenous Infusion) Drug: Nadroparin (subcutaneous group)	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 8, 2015

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous group	Drug: Nadroparin (intravenous Infusion) Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU
Active Comparator: Subcutaneous group	Drug: Nadroparin (subcutaneous group) Subcutaneous route of administration of nadroparin 3800 IU

Arm

Intervention/Treatment

Experimental: Intravenous group

Drug: Nadroparin (intravenous Infusion)

Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU

Active Comparator: Subcutaneous group

Drug: Nadroparin (subcutaneous group)

Subcutaneous route of administration of nadroparin 3800 IU

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
AUC (0-24h) [0-24 hours]
Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Clinique Saint Pierre Ottignies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicolas De Schryver, Principal investigator, Clinique Saint Pierre Ottignies

ClinicalTrials.gov Identifier:

NCT04982055

Other Study ID Numbers:

IV vs SC LMWH ICU

First Posted:

Jul 29, 2021

Last Update Posted:

Jul 29, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Critical Illness

Nadroparin

Study Results

No Results Posted as of Jul 29, 2021