Impact of an Intensified Thromboprofylaxis Protocol in COVID-19

NCT04394000 | Completed

• 1 other identifier: Jessa_20.48
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate and compare the mortality, the incidence of DVT and the incidence of kidney and liver failure in patients admitted to the ICU before and after the implementation of an intensified thromboprofylaxis protocol on 31st of March 2020. Patients in the before group are admitted at the ICU from 13/3/2020-30/3/2020 and patients in the after group are admitted to the ICU from 31/3 until 20/4/2020.

Conditions

COVID19; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 2 week mortality

  mortality was assessed in all COVID 19 patients admitted to the ICU

  2 weeks after admission at ICU

Secondary Outcomes (12)

• incidence of venous thromboembolism

  during ICU stay up till 3th of May 2020

• 1 week mortality

  1 week after admission at ICU

• 3 week mortality

  3 weeks after admission at ICU

• 1 month mortality

  1 month after admission at ICU

• incidence of kidney failure

  during ICU stay up till 3th of May 2020

Study Arms (2)

Before or control group

All patients admitted to ICU from March 13th 2020 until March 30th 2020 received routine low dose pharmacological VTE prophylaxis

Other: standard protocol

After or intervention group

On March 31th 2020 an individualised, more aggressive thromboprophylaxis protocol was implemented. This individualised protocol contains three cornerstones: an increase in dosage of prophylactic LMWH close to therapeutic doses, introduction of routine venous ultrasonography and daily measurements of plasma anti-factor Xa activity

Other: thromboprofylaxis protocol

Interventions

thromboprofylaxis protocol OTHER

This individualised protocol contains three cornerstones: an increase in dosage of prophylactic LMWH close to therapeutic doses, introduction of routine venous ultrasonography and daily measurements of plasma anti-factor Xa activity

After or intervention group

standard protocol OTHER

This protocol contains a routine low dose pharmacological venous thromboembolism (VTE) prophylaxis with LMWH

Before or control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult COVID19+ patients admitted to the ICU from 13th of March until 20th of April 2020.

You may qualify if:

• \- All adult COVID19+ patients admitted to the ICU from 13th of March until 20th of April 2020.

You may not qualify if:

• \- Patients younger than 18 years old.

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa hospital

Hasselt, 3500, Belgium

Location

Related Publications (1)

• Stessel B, Vanvuchelen C, Bruckers L, Geebelen L, Callebaut I, Vandenbrande J, Pellens B, Van Tornout M, Ory JP, van Halem K, Messiaen P, Herbots L, Ramaekers D, Dubois J. Impact of implementation of an individualised thromboprophylaxis protocol in critically ill ICU patients with COVID-19: A longitudinal controlled before-after study. Thromb Res. 2020 Oct;194:209-215. doi: 10.1016/j.thromres.2020.07.038. Epub 2020 Jul 22.

  PMID: 32788120 DERIVED

MeSH Terms

Conditions

COVID-19; Thromboembolism

Interventions

AIEOP acute lymphoblastic leukemia protocol

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 19, 2020
• Study Start: May 4, 2020
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)