Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07365644

Acronym

PANTHER

Enrollment

1111

Registered

2026-01-26

Start date

2026-01-01

Completion date

2028-02-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylactic Anticoagulation

Keywords

intensive care unit, Prophylactic ANTicoagulation, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of hemorrhagic and thrombotic events in patients with renal failure in intensive care receiving heparin thromboprophylaxis	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

Countries

France

Contacts

CONTACTLev VOLKOV, MD

lvolkov@ch-lemans.fr02 43 43 43 03

CONTACTEglantine ROUANET

erouanet@ch-lemans.fr02 44 71 07 31

Outcome results