Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant ProphylaxisNCT04671160
Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.
An observational study of Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Dose of anticoagulant prophylaxis in patients with continuous veno-venous hemodiafiltration may be insufficient to keep anti-Xa factor activity in prophylactic range. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis
- What is being tested?
- Assessment the activity of anti-Xa factor.
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jan 2021to 30 Sep 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All male and female Intensive Care Unit adult patients (18 - 80 y.o.) requiring continuous veno-venous hemodiafiltration (CVVHDF) and receiving prophylactic doses of enoxaparin or fondaparinux.
Who may be able to join
- All adult Intensive Care Unit patients between 18 and 80 years old requiring treatment with CVVHDF;
- Indications for anticoagulant prophylaxis with enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily;
- Treatment with continuous veno-venous hemodiafiltration.
Who cannot join
- Indications for low molecular weight heparin use other than anticoagulant prophylaxis;
- Intracranial hemorrhage;
- Incident of serious bleeding within a week before admission to ICU, if not managed;
- Disseminated intravascular coagulopathy;
- Heparin induced thrombocytopenia;
- Hypersensitivity or allergic reaction to enoxaparin or fondaparinux;
Show all 10Show fewer
- Thrombocytopenia < 50 G/L;
- Prothrombin time < 20% or INR (international normalized ratio) > 1.7;
- Use of antiplatelet drugs;
- Presence of congenital coagulopathy.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship, 80-214
Radoslaw Owczuk, Prof., 583493270 ext. 0048, klanest@gumed.edu.pl
Aleksander Aszkielowicz, M.D., 509465855 ext. 0048, aszkielowicz@gumed.edu.pl
About this study
Dose of anticoagulant prophylaxis in patients with continuous veno-venous hemodiafiltration may be insufficient to keep anti-Xa factor activity in prophylactic range.
Read the detailed description
Coagulation disorders are one of the most common complications in critically ill patients. Among them deep vein thrombosis and pulmonary embolism are the most significant factors increasing morbidity and mortality in ICU patients. Use of anticoagulant prophylaxis aims to prevent these dangerous complications. Most commonly used anticoagulant prophylaxis agents are low molecular weight heparins (LMWH). LMWH therapeutic efficiency is measured with activity of anti-Xa factor, that should range between 0.2 and 0.4 IU/mL in order to prevent thrombotic complications. Due to grave general condition, critically ill patients may often develop acute kidney injury (AKI), that requires renal replacement therapy (RRT). Because of haemodynamic instability the safest therapeutic choice seems to be continuous veno-venous hemodiafiltration (CVVHDF). This RRT mode removes particles in the size of few daltons even up to 10 kilodaltons (kDa) such as metabolic product waste, ions, hormones etc. LMWH with average molecular weight of 4.5 kDa and fondaparinux with average molecular weight of 1.7 kDa may be removed during CVVHDF resulting in insufficient activity of anti-Xa factor thus increasing the risk of thrombotic complications in critically ill patients.
- Being tested
- Assessment the activity of anti-Xa factor.
- Keywords
- continuous veno-venous hemodiafiltration, enoxaparin, low molecular weight heparin, LMWH, CVVHDF, anticoagulant prophylaxis, critically ill, fondaparinux, anti-Xa activity
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment the activity of anti-Xa factor.Diagnostic test
Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis. Receives: Diagnostic Test: Assessment the activity of anti-Xa factor. | |
| 2 | Group treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis. Receives: Diagnostic Test: Assessment the activity of anti-Xa factor. | |
| 3 | Group not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis. Receives: Diagnostic Test: Assessment the activity of anti-Xa factor. | |
| 4 | Group not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis. Receives: Diagnostic Test: Assessment the activity of anti-Xa factor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Xa assay
Anti-Xa assay as a tool to measure anticoagulation activity in subjects just before administration of anticoagulant prophylaxis, 3 hours, 6 hours and 9 hours after administration of prophylactic dose of enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily.
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start4 Jan 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant ProphylaxisStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671160
- Sponsor's protocol ID
- M000000346978
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Aszkielowicz A, Steckiewicz KP, Owczuk R. Evaluating the impact of continuous venovenous hemodiafiltration on the efficacy of prophylactic fondaparinux doses: a prospective single-center observational study. Sci Rep. 2025 May 24;15(1):18083. doi: 10.1038/s41598-025-03365-1.
PubMed 40413237
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT04671160
- Acronym / sponsor ID
- M000000346978
- Keywords
- continuous veno-venous hemodiafiltration, enoxaparin, low molecular weight heparin, LMWH, CVVHDF, anticoagulant prophylaxis, critically ill, fondaparinux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 4 Jan 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 17 Dec 2020 (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.
Dose of anticoagulant prophylaxis in patients with continuous veno-venous hemodiafiltration may be insufficient to keep anti-Xa factor activity in prophylactic range.
Detailed description
Coagulation disorders are one of the most common complications in critically ill patients. Among them deep vein thrombosis and pulmonary embolism are the most significant factors increasing morbidity and mortality in ICU patients. Use of anticoagulant prophylaxis aims to prevent these dangerous complications. Most commonly used anticoagulant prophylaxis agents are low molecular weight heparins (LMWH). LMWH therapeutic efficiency is measured with activity of anti-Xa factor, that should range between 0.2 and 0.4 IU/mL in order to prevent thrombotic complications. Due to grave general condition, critically ill patients may often develop acute kidney injury (AKI), that requires renal replacement therapy (RRT). Because of haemodynamic instability the safest therapeutic choice seems to be continuous veno-venous hemodiafiltration (CVVHDF). This RRT mode removes particles in the size of few daltons even up to 10 kilodaltons (kDa) such as metabolic product waste, ions, hormones etc. LMWH with average molecular weight of 4.5 kDa and fondaparinux with average molecular weight of 1.7 kDa may be removed during CVVHDF resulting in insufficient activity of anti-Xa factor thus increasing the risk of thrombotic complications in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Assessment the activity of anti-Xa factor.Group treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis. |
| 2 | – | Diagnostic Test: Assessment the activity of anti-Xa factor.Group treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis. |
| 3 | – | Diagnostic Test: Assessment the activity of anti-Xa factor.Group not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis. |
| 4 | – | Diagnostic Test: Assessment the activity of anti-Xa factor.Group not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All male and female Intensive Care Unit adult patients (18 - 80 y.o.) requiring continuous veno-venous hemodiafiltration (CVVHDF) and receiving prophylactic doses of enoxaparin or fondaparinux.
Key inclusion criteria (3 listed)
- All adult Intensive Care Unit patients between 18 and 80 years old requiring treatment with CVVHDF;
- Indications for anticoagulant prophylaxis with enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily;
- Treatment with continuous veno-venous hemodiafiltration.
Key exclusion criteria (10 listed)
- Indications for low molecular weight heparin use other than anticoagulant prophylaxis;
- Intracranial hemorrhage;
- Incident of serious bleeding within a week before admission to ICU, if not managed;
- Disseminated intravascular coagulopathy;
- Heparin induced thrombocytopenia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment the activity of anti-Xa factor.Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis. | Diagnostic test | 1, 2, 3, 4 |
Primary outcome
Anti-Xa assay
Time frame: 9 hours
Anti-Xa assay as a tool to measure anticoagulation activity in subjects just before administration of anticoagulant prophylaxis, 3 hours, 6 hours and 9 hours after administration of prophylactic dose of enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 40413237Aszkielowicz A, Steckiewicz KP, Owczuk R. Evaluating the impact of continuous venovenous hemodiafiltration on the efficacy of prophylactic fondaparinux doses: a prospective single-center observational study. Sci Rep. 2025 May 24;15(1):18083. doi: 10.1038/s41598-025-03365-1.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis, run by Medical University of Gdansk at 1 site in Poland.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksander Aszkielowicz, M.D. (509465855 ext. 0048, aszkielowicz@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Xa assay (time frame: 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671160, which also lists 1 linked publication.
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 17 Dec 2020.