Unfractionated Heparin in COVID-19 and Non-COVID-19 Patients

NCT05509647 | Completed

• 1 other identifier: CoCo 2022-020
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of ICU patients with COVID-19 show profound activation of coagulation, potentially resulting in thromboembolic events. In the treatment of these thromboembolic events it seemed that very high dosages of unfractionated heparin were necessary to achieve therapeutic values of aPTT and anti-Xa levels. The aim of this study is to explore whether heparin dosages are higher in COVID-19 patients compared to non-COVID-19 patients, to determine the correlation between aPTT and anti-Xa values and to explore possible causes for non-correlating aPTT and anti-Xa, including CRP and AT plasma levels.

Conditions

Heparin Overdose of Undetermined Intent; COVID-19

Outcome Measures

Primary Outcomes (1)

• Heparin dosage

  To determine whether heparin dosages are higher in COVID-19 patients compared to non COVID-19 patients.

  Until end of heparin therapy or ICU discharge, whatever comes first.

Secondary Outcomes (3)

• Correlation between aPTT and anti-Xa values

  Until end of heparin therapy or ICU discharge, whatever comes first.

• Correlation between non-correlating aPTT and Anti-Xa levels and CRP

  Until end of heparin therapy or ICU discharge, whatever comes first.

• Correlation between non-correlating aPTT and Anti-Xa levels and AT plasma levels

  Until end of heparin therapy or ICU discharge, whatever comes first.

Study Arms (2)

Covid-19 patients

Adult patients treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml. All patients have Covid-19 proven by PCR or nose- or airway swab. Patients admitted to the ICU from the 15th of March 2020 until January 2022.

Drug: Unfractionated heparin

non-COVID-19 patients

Adult patients treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml. Patients admitted to the ICU between the 1st of January 2014 and the 1st of January 2020 are included.

Drug: Unfractionated heparin

Interventions

Unfractionated heparin DRUG

Patients are treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa levels of 0.3-0.7 iE/ml

Covid-19 patients; non-COVID-19 patients

Eligibility Criteria

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

Study Population

Patients admitted to the ICU in the above mentioned periods of time and in need for unfractionated heparin treatment are eligible to participate in the study. There is no selection bias: all patients fulfilling the entry criteria will be included.

You may qualify if:

• Covid-19 disease proven by PCR of nose- or airway sample
• Age ≥ 18 years
• Admitted to the ICU from the 15th of March 2020 until 1st of January 2022
• Treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml
• Age ≥ 18 years
• Admitted to the ICU between the 1st of January 2014 and 1st of January 2020
• Treated with unfractionated heparin aiming at aPTT 60-80 sec and/or anti-Xa level 0.3-0.7 iE/ml

You may not qualify if:

• \- Treatment with anticoagulants other than UFH or fibrinolytics

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2333ZA, Netherlands

Location

Related Publications (4)

• Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

  PMID: 32105632 BACKGROUND

• Thachil J, Tang N, Gando S, Falanga A, Levi M, Clark C, Iba T, Cattaneo M. Type and dose of heparin in Covid-19: Reply. J Thromb Haemost. 2020 Aug;18(8):2063-2064. doi: 10.1111/jth.14870. Epub 2020 May 11. No abstract available.

  PMID: 32329221 BACKGROUND

• Arachchillage DRJ, Kamani F, Deplano S, Banya W, Laffan M. Should we abandon the APTT for monitoring unfractionated heparin? Thromb Res. 2017 Sep;157:157-161. doi: 10.1016/j.thromres.2017.07.006. Epub 2017 Jul 6.

  PMID: 28759760 BACKGROUND

• White D, MacDonald S, Bull T, Hayman M, de Monteverde-Robb R, Sapsford D, Lavinio A, Varley J, Johnston A, Besser M, Thomas W. Heparin resistance in COVID-19 patients in the intensive care unit. J Thromb Thrombolysis. 2020 Aug;50(2):287-291. doi: 10.1007/s11239-020-02145-0.

  PMID: 32445064 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Heparin

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Evert de Jonge, MD, PhD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Intensive Care Department

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: August 22, 2022
• Study Start: January 1, 2014
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)