Is Anti-Factor Xa Associated With Outcome in Patients With Critical COVID-19 on Low-Molecular-Weight Heparin?

NCT05256524 | Completed

• 1 other identifier: AntiFactorXa in Covid-19
• Study Type: observational
• Target: 1,520
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with critical COVID-19 are hyper-coagulable and optimal thromboprophylaxis treatment differs with stage and severity. The most commonly used drug for thromboprophylaxis in the intensive care unit (ICU) is low-molecular-weight heparin (LMWH). In contrast to unfractionated heparins, the effects of LMWH usually do not require monitoring. Exceptions from this are when elimination of LMWH is impaired, extremes in age and weight, to identify deviations from predicted pharmacokinetics, and if there is an unexpected clinical response. The unexpected high incidence of thromboembolic complications among patients with critical COVID-19 compared to critically ill non-COVID-19 patients could motivate monitoring. The activity of LMWH is monitored by quantifying the presence of anti-Factor Xa (aFXa). The aim of this study is to investigate if the level and the monitoring frequency of aFXa is associated to mortality, thrombosis and bleeding in patients with critical COVID-19 treated with LMWH and therefore could be used as a potential tool to guide LMWH-treatment.

Conditions

Covid19; Thromboembolism; Bleeding

Keywords

Low-molecular-weight Heparin; Anti-Factor Xa; Critical Care

Outcome Measures

Primary Outcomes (1)

• Mortality

  90-day mortality

  90 days from ICU admission

Secondary Outcomes (2)

• Thromboembolic events

  28 days from ICU-admission

• Bleeding events

  28 days from ICU-admission

Study Arms (2)

Patients with critical COVID-19 responding to LMWH treatment

Responders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

Drug: The effect of LMWH; Diagnostic Test: Monitoring frequency of aFXa-levels

Patients with critical COVID-19 not responding to LMWH treatment

Non-responders are defined as patients who do not achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

Drug: The effect of LMWH; Diagnostic Test: Monitoring frequency of aFXa-levels

Interventions

The effect of LMWH DRUG

Quantified by aFXa-levels

Patients with critical COVID-19 not responding to LMWH treatment; Patients with critical COVID-19 responding to LMWH treatment

Monitoring frequency of aFXa-levels DIAGNOSTIC_TEST

The frequency of aFXa-levels being sampled, analysed and integrated as a possible part of the basis for clinical decisionmaking

Patients with critical COVID-19 not responding to LMWH treatment; Patients with critical COVID-19 responding to LMWH treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with critical COVID-19 and respiratory failure admitted to ICU at Södersjukhuset, Karolinska Sjukhuset and Skånes Universitetssjukhus, in Sweden, between March 1 2020 and May 31 2021 are eligible. Patients will be included on their first admission to the ICU if admitted more than once. First admission can be replaced by the second one if the first one is considered very short/insignificant compared to the second one. If a patient is transferred from one ICU to another this will be considered the same admission but they will be grouped according to their initial ICU.

You may qualify if:

• Patients with critical COVID-19 and respiratory failure
• Positive SARS-CoV-2 test
• LMWH-effect monitored by aFXa, as a trough or peak value, after at least four doses at a twice daily regime

You may not qualify if:

• Diagnosed thromboembolism or major bleeding during their COVID-illness prior to ICU-admission or as a reason or contributing factor for the ICU-admission.
• Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible

Sponsors & Collaborators

• Karolinska Institutet: lead
• Lund University: collaborator

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (1)

• Jonmarker S, Litorell J, Alarcon F, Al-Abani K, Bjorkman S, Farm M, Grip J, Soderberg M, Hollenberg J, Wahlin RR, Kander T, Rimling L, Martensson J, Joelsson-Alm E, Dahlberg M, Cronhjort M. A retrospective multicenter cohort study of the association between anti-Factor Xa values and death, thromboembolism, and bleeding in patients with critical COVID-19. Thromb J. 2023 Oct 2;21(1):101. doi: 10.1186/s12959-023-00541-z.

  PMID: 37784131 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

anti-Factor Xa

MeSH Terms

Conditions

COVID-19; Thromboembolism; Hemorrhage

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Jonmarker, MD

  Stockholm South General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD-student

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: August 29, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

SE (1)