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

Centre Hospitalier le Mans

Status: Not yet enrolling

Conditions: Prophylactic Anticoagulation

Study type: Observational

Funder types: Other

Identifiers

NCT07365644

CHM-2025/S03/14

Details and patient eligibility

About

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.

Enrollment: 1,111 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,111 participants in 1 patient group

patient with impaired renal function in intensive care