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NCT Number: NCT07365644

Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eglantine ROUANET

CONTACT

[email protected]

02 44 71 07 31

Lev VOLKOV, MD

CONTACT

[email protected]

02 43 43 43 03

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: PANTHER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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