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

NCT04982055 | Completed Phase 4

• 1 other identifier: IV vs SC LMWH ICU
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Trough anti-Xa activity

  Trough anti-Xa activity measured 24 hours after start of low molecular weight administration

• AUC (0-24h)

  0-24 hours

Study Arms (2)

Intravenous group

EXPERIMENTAL

Drug: Nadroparin (intravenous Infusion)

Subcutaneous group

ACTIVE COMPARATOR

Drug: Nadroparin (subcutaneous group)

Interventions

Nadroparin (intravenous Infusion) DRUG

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

Intravenous group

Nadroparin (subcutaneous group) DRUG

Subcutaneous route of administration of nadroparin 3800 IU

Subcutaneous group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique Saint Pierre Ottignies: lead

Related Publications (1)

• De Schryver N, Serck N, Eeckhoudt S, Laterre PF, Wittebole X, Gerard L. Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial. J Crit Care. 2022 Aug;70:154029. doi: 10.1016/j.jcrc.2022.154029. Epub 2022 Apr 2.

  PMID: 35381407 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Nadroparin; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 29, 2021
• Study Start: April 8, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share