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ClinicalTrials.gov ID

NCT07365644

Lead Sponsor

Centre Hospitalier le MansOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

1,111Estimated

Last Update Posted

Jan 26, 2026Actual

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Feb 1, 2028Estimated

Completion Date

Feb 1, 2028Estimated

Official Title

Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment

Brief 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.

• Prophylactic Anticoagulation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Centre Hospitalier le MansOTHER

renaud.prevel@u-bordeaux.fr05 57 82 08 71

cecile.aubron@chu-brest.fr0298347181

ducheyron-d@chu-caen.fr02 31 06 47 16

p.bouju@ghbs.bzh02-97-06-96-94

guillaume.louis@chr-metz-thionville.fr03 87 18 63 17

s.gibot@chru-nancy.fr03.83.15.52.75

jean.reignier@chu-nantes.fr02 53 48 28 64

gregoire.muller@chu-orleans.fr02 38 51 44 46

Amaud.THILLE@chu-poitiers.fr05 49 44 43 67

Jeanmarc.TADIE@chu-rennes.fr02 99 28 42 48

guillaume.granier@chr-metz-thionville.fr03 87 55 77 50

charlotte.salmon@univ-tours.fr02 47 47 38 55