Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment (PANTHER)

January 16, 2026 updated by: Centre Hospitalier le Mans

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49000
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Pierre ASFAR, PhD
      • Bordeaux, France, 33000
        • CHU Bordeaux
        • Contact:
        • Principal Investigator:
          • Renaud PREVEL, MD
      • Brest, France, 29609
        • CHU Brest
        • Contact:
        • Principal Investigator:
          • Cécile AUBRON, MD
      • Caen, France, 14000
        • CHU CAEN
        • Contact:
        • Principal Investigator:
          • Damien DU CHEYRON, MD
      • Le Mans, France, 72000
        • Centre Hospitalier Le Mans
      • Lorient, France, 56322
        • Groupe Hospitalier Bretagne Sud
        • Contact:
        • Principal Investigator:
          • Piere BOUJU, MD
      • Metz, France, 57000
      • Nancy, France, 54511
        • CHRU Nancy
        • Contact:
        • Principal Investigator:
          • Sébastien GIBOT, PhD
      • Nantes, France, 44000
        • CHU Nantes
        • Contact:
        • Principal Investigator:
          • Jean REIGNIER, PhD
      • Orléans, France, 45100
        • Chu Orleans
        • Contact:
        • Principal Investigator:
          • Guillaume MULLER, MD
      • Poitiers, France, 86000
        • CHU Poitiers
        • Contact:
        • Principal Investigator:
          • Arnaud THILLE, PhD
      • Rennes, France, 35000
        • CHU Rennes
        • Contact:
        • Principal Investigator:
          • Jean-Marc TADIE, PhD
      • Saint-Nazaire, France, 44600
        • Centre Hospitalier de Saint-Nazaire
        • Contact:
        • Principal Investigator:
          • Julien LORBER, MD
      • Thionville, France, 57100
      • Tours, France, 37000
        • CHU Tours
        • Contact:
        • Principal Investigator:
          • Charlotte SALMON GANDONNIERE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with impaired renal function in intensive care

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patient with impaired renal function in intensive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hemorrhagic and thrombotic events in patients with renal failure in intensive care receiving heparin thromboprophylaxis
Time Frame: Day 1 to Day 28
Incidence of hemorrhagic and thrombotic events was evaluated by occurrence of major bleeding and occurrence of a venous thromboembolic event
Day 1 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHM-2025/S03/14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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