Prophylactic AnticoagulationPANTHERNCT07365644
Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment
An observational study of Prophylactic Anticoagulation, run by Centre Hospitalier le Mans at 15 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prophylactic Anticoagulation
- How many people
- 1,111 participants
- Where
- 15 sitesFrance
- Study dates
- 1 Jan 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with impaired renal function in intensive care
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites
CHU Angers
Angers, 49000
Pierre ASFAR, PhD, 02 41 35 38 15, PiAsfar@chu-angers.fr
Pierre ASFAR, PhD
CHU bordeaux
Bordeaux, 33000
Renaud PREVEL, MD, 05 57 82 08 71, renaud.prevel@u-bordeaux.fr
Renaud PREVEL, MD
CHU Brest
Brest, 29609
Cécile AUBRON, MD, 0298347181, cecile.aubron@chu-brest.fr
Cécile AUBRON, MD
CHU Caen
Caen, 14000
Damien DU CHEYRON, MD, 02 31 06 47 16, ducheyron-d@chu-caen.fr
Damien DU CHEYRON, MD
Centre Hospitalier Le Mans
Le Mans, 72000
Groupe Hospitalier Bretagne Sud
Lorient, 56322
Pierre BOUJU, MD, 02-97-06-96-94, p.bouju@ghbs.bzh
Piere BOUJU, MD
CHR Metz-Thionville site Mercy
Metz, 57000
Guillaume LOUIS, MD, 03 87 18 63 17, guillaume.louis@chr-metz-thionville.fr
Guillaume LOUIS, MD
CHRU Nancy
Nancy, 54511
Sébastien GIBOT, PhD, 03.83.15.52.75, s.gibot@chru-nancy.fr
Sébastien GIBOT, PhD
CHU Nantes
Nantes, 44000
Jean REIGNIER, PhD, 02 53 48 28 64, jean.reignier@chu-nantes.fr
Jean REIGNIER, PhD
CHU Orléans
Orléans, 45100
Grégoire MULLER, MD, 02 38 51 44 46, gregoire.muller@chu-orleans.fr
Guillaume MULLER, MD
CHU Poitiers
Poitiers, 86000
Arnaud THILLE, PhD, 05 49 44 43 67, Amaud.THILLE@chu-poitiers.fr
Arnaud THILLE, PhD
CHU Rennes
Rennes, 35000
Jean-Marc TADIE, PhD, 02 99 28 42 48, Jeanmarc.TADIE@chu-rennes.fr
Jean-Marc TADIE, PhD
Centre Hospitalier de Saint-Nazaire
Saint-Nazaire, 44600
Julien LORBER, MD, 02.72.27.84.03, j.lorber@ch-saintnazaire.fr
Julien LORBER, MD
CHR Metz-Thionville Hôpital Bel-Air
Thionville, 57100
Guillaume GRANIER, MD, 03 87 55 77 50, guillaume.granier@chr-metz-thionville.fr
Guillaume GRANIER, MD
CHU Tours
Tours, 37000
Charlotte SALMON GANDONNIERE, MD, 02 47 47 38 55, charlotte.salmon@univ-tours.fr
Charlotte SALMON GANDONNIERE, MD
About this study
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.
Read more
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.
- Conditions
- Prophylactic Anticoagulation
- Keywords
- intensive care unit, Prophylactic ANTicoagulation, Renal impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient with impaired renal function in intensive care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylactic AnticoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365644
- Sponsor's protocol ID
- CHM-2025/S03/14
- Acronym
- PANTHER
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment
- ClinicalTrials.gov ID
- NCT07365644
- Acronym / sponsor ID
- PANTHER / CHM-2025/S03/14
- Conditions
- Prophylactic Anticoagulation
- Keywords
- intensive care unit, Prophylactic ANTicoagulation, Renal impairment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,111 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with impaired renal function in intensive care | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with impaired renal function in intensive care
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prophylactic Anticoagulation, run by Centre Hospitalier le Mans at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lev VOLKOV, MD (02 43 43 43 03, lvolkov@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hemorrhagic and thrombotic events in patients with renal failure in intensive care receiving heparin thromboprophylaxis (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.