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Not yet recruitingNCT07365644PANTHERUpdated Jan 26, 2026

Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment

An observational study in Prophylactic Anticoagulation, sponsored by Centre Hospitalier le Mans. Not yet recruiting at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Centre Hospitalier le Mans · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,111
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Prophylactic Anticoagulation

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Keywords

  • intensive care unit
  • Prophylactic ANTicoagulation
  • Renal impairment
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 1,111 is above the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Centre Hospitalier le Mans is the lead sponsor of 42 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with impaired renal function in intensive care

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,111 participants (estimated)
Patient registry
No

Groups and cohorts

  • patient with impaired renal function in intensive care
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What researchers measure

Primary outcomes

  1. Incidence of hemorrhagic and thrombotic events in patients with renal failure in intensive care receiving heparin thromboprophylaxis

    Incidence of hemorrhagic and thrombotic events was evaluated by occurrence of major bleeding and occurrence of a venous thromboembolic event

    Time frame: Day 1 to Day 28

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Study locations

15 sites
  • CHU Angers
    Angers, 49000, France
    • Pierre ASFAR, PhD · Contact · PiAsfar@chu-angers.fr · 02 41 35 38 15
    • Pierre ASFAR, PhD · Principal investigator
  • CHU bordeaux
    Bordeaux, 33000, France
  • CHU Brest
    Brest, 29609, France
  • CHU Caen
    Caen, 14000, France
    • Damien DU CHEYRON, MD · Contact · ducheyron-d@chu-caen.fr · 02 31 06 47 16
    • Damien DU CHEYRON, MD · Principal investigator
  • Centre Hospitalier Le Mans
    Le Mans, 72000, France
  • Groupe Hospitalier Bretagne Sud
    Lorient, 56322, France
    • Pierre BOUJU, MD · Contact · p.bouju@ghbs.bzh · 02-97-06-96-94
    • Piere BOUJU, MD · Principal investigator
  • CHR Metz-Thionville site Mercy
    Metz, 57000, France
  • CHRU Nancy
    Nancy, 54511, France
    • Sébastien GIBOT, PhD · Contact · s.gibot@chru-nancy.fr · 03.83.15.52.75
    • Sébastien GIBOT, PhD · Principal investigator
  • CHU Nantes
    Nantes, 44000, France
  • CHU Orléans
    Orléans, 45100, France
  • CHU Poitiers
    Poitiers, 86000, France
  • CHU Rennes
    Rennes, 35000, France
  • Centre Hospitalier de Saint-Nazaire
    Saint-Nazaire, 44600, France
  • CHR Metz-Thionville Hôpital Bel-Air
    Thionville, 57100, France
  • CHU Tours
    Tours, 37000, France
    • Charlotte SALMON GANDONNIERE, MD · Contact · charlotte.salmon@univ-tours.fr · 02 47 47 38 55
    • Charlotte SALMON GANDONNIERE, MD · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07365644
Lead sponsor
Centre Hospitalier le Mans
Responsible party
Sponsor
First posted
Jan 26, 2026
Start date
Jan 1, 2026 (estimated)
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Jan 26, 2026

Study contacts

Lev VOLKOV, MD
Contact
lvolkov@ch-lemans.fr
02 43 43 43 03
Eglantine ROUANET
Contact
erouanet@ch-lemans.fr
02 44 71 07 31

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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