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Clinical Trials in France / NCT07365644
Starting soon Observational

Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment

NCT07365644 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-01-01
Last updated
2026-01-26

Condition(s) studied

Prophylactic Anticoagulation

Study summary

Intensive care patients have an increased risk of venous thromboembolic events (deep vein thrombosis (DVT) and pulmonary embolism (PE)) due to the presence of general risk factors for thrombosis (age, immobilization, obesity, prothrombotic history, etc.), but also risk factors specifically related to their stay in intensive care (sepsis, vasopressors, organ failure, mechanical ventilation, sedation, renal failure, central venous catheters). In addition, these same patients also have an increased risk of hemorrhagic events, mainly associated with coagulation disorders and thrombocytopenia.

Given this increased risk of thrombosis, it is recommended that heparin thromboprophylaxis be used in intensive care patients in the absence of contraindications.

In current practice, when faced with a patient with impaired renal function, there is significant heterogeneity in the prescription of thromboprophylaxis between centers and intensive care physicians: some will use enoxaparin, dalteparin, or tinzaparin regardless of renal function, while others will use subcutaneous calciparin or IVSE UFH.

The PANTHER study is a prospective, multicenter, observational study that aims to evaluate the safety and efficacy of heparin thromboprophylaxis in critically ill patients with renal failure. The goal is to assess whether there is a difference in bleeding risk and thromboprophylaxis efficacy depending on the molecule used.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Presence of impaired renal function (one of the two criteria must be met, both criteria may be met): Glomerular filtration rate (GFR) \<30ml/min/1.7m² according to the MDRD or CKD-EPI formula. Acute renal failure (observed or presumed increase in creatinine in the last 7 days) KDIGO stage 3 (creatinine ≥3 times baseline creatinine or ≥354 µmol/L (4 mg/dL) or urine output \<0.3 mL/kg/h for ≥24 hours or initiation of extrarenal clearance or anuria for ≥12 hours) \- Expected length of stay in intensive care ≥48 hours Exclusion Criteria: * Age ≤ 18 years * Long-term dialysis patient * Current or recent hemorrhage during this hospitalization * Patient receiving curative anticoagulation or treated long-term prior to admission with curative anticoagulation. * Thrombosis present on admission

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
CHU Angers Angers France
CHU bordeaux Bordeaux France
CHU Brest Brest France
CHU Caen Caen France
Centre Hospitalier Le Mans Le Mans France
Groupe Hospitalier Bretagne Sud Lorient France
CHR Metz-Thionville site Mercy Metz France
CHRU Nancy Nancy France
CHU Nantes Nantes France
CHU Orléans Orléans France
CHU Poitiers Poitiers France
CHU Rennes Rennes France
Centre Hospitalier de Saint-Nazaire Saint-Nazaire France
CHR Metz-Thionville Hôpital Bel-Air Thionville France
CHU Tours Tours France

More Centre Hospitalier le Mans trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07365644 on ClinicalTrials.gov ↗ ← All trials in France