NCT07365644

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,111

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Feb 2028

Study Start

First participant enrolled

January 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

January 26, 2026

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

intensive care unitProphylactic ANTicoagulationRenal impairment

Outcome Measures

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

    Day 1 to Day 28

Study Arms (1)

patient with impaired renal function in intensive care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with impaired renal function in intensive care

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU Angers

Angers, 49000, France

Location

CHU bordeaux

Bordeaux, 33000, France

Location

CHU Brest

Brest, 29609, France

Location

CHU Caen

Caen, 14000, France

Location

Centre Hospitalier Le Mans

Le Mans, 72000, France

Location

Groupe Hospitalier Bretagne Sud

Lorient, 56322, France

Location

CHR Metz-Thionville site Mercy

Metz, 57000, France

Location

CHRU Nancy

Nancy, 54511, France

Location

CHU Nantes

Nantes, 44000, France

Location

CHU Orléans

Orléans, 45100, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CHU Rennes

Rennes, 35000, France

Location

Centre Hospitalier de Saint-Nazaire

Saint-Nazaire, 44600, France

Location

CHR Metz-Thionville Hôpital Bel-Air

Thionville, 57100, France

Location

CHU Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

January 26, 2026

Record last verified: 2025-12

Locations