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Impact of an Intensified Thromboprofylaxis Protocol in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394000
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jessa Hospital

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.

Condition or disease Intervention/treatment
COVID19 Thromboembolism Other: thromboprofylaxis protocol Other: standard protocol

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Study Type : Observational [Patient Registry]
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Month
Official Title: Impact of Implementation of an Intensified Thromboprofylaxis Protocol in in Critically Ill ICU Patients With COVID-19: a Longitudinal Controlled Before-after Study
Actual Study Start Date : May 4, 2020
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020

Group/Cohort Intervention/treatment
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
This protocol contains a routine low dose pharmacological venous thromboembolism (VTE) prophylaxis with LMWH

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
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




Primary Outcome Measures :
  1. 2 week mortality [ Time Frame: 2 weeks after admission at ICU ]
    mortality was assessed in all COVID 19 patients admitted to the ICU


Secondary Outcome Measures :
  1. incidence of venous thromboembolism [ Time Frame: during ICU stay up till 3th of May 2020 ]
    the incidence of venous thromboembolism was evaluated in all COVID 19 patients admitted to the ICU

  2. 1 week mortality [ Time Frame: 1 week after admission at ICU ]
    mortality was assessed in all COVID 19 patients admitted to the ICU

  3. 3 week mortality [ Time Frame: 3 weeks after admission at ICU ]
    mortality was assessed in all COVID 19 patients admitted to the ICU

  4. 1 month mortality [ Time Frame: 1 month after admission at ICU ]
    mortality was assessed in all COVID 19 patients admitted to the ICU

  5. incidence of kidney failure [ Time Frame: during ICU stay up till 3th of May 2020 ]
    incidence of acute kidney failure in all COVID 19 patients admitted to the ICU

  6. incidence of continuous renal replacement therapy (CRRT) [ Time Frame: during ICU stay up till 3th of May 2020 ]
    incidence of continuous renal replacement therapy (CRRT) in all COVID 19 patients admitted to the ICU

  7. lowest PaO2/FiO2 (P/F) ratio [ Time Frame: during ICU stay up till 3th of May 2020 ]
    evaluation of the lowest P/F ratio in all COVID 19 patients admitted to the ICU

  8. highest Sequential Organ Failure Assessment (SOFA) score [ Time Frame: during ICU stay up till 3th of May 2020 ]
    evaluation of the highest SOFA score in all COVID 19 patients admitted to the ICU

  9. length of stay [ Time Frame: during ICU and hospital stay up till 3th of May 2020 ]
    evaluation of the length of stay in ICU and hospital of all COVID 19 patients admitted to the ICU

  10. highest bilirubin [ Time Frame: during ICU stay up till 3th of May 2020 ]
    evaluation of the highest bilirubine level in all COVID 19 patients admitted to the ICU

  11. highest ( AST [ Time Frame: during ICU stay up till 3th of May 2020 ]
    evaluation of the highest AST level in all COVID 19 patients admitted to the ICU

  12. highest Aspartaat-Amino-Transferase (ALT) [ Time Frame: during ICU stay up till 3th of May 2020 ]
    evaluation of the highest ALT level in all COVID 19 patients admitted to the ICU



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All adult COVID19+ patients admitted to the ICU from 13th of March until 20th of April 2020.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Patients younger than 18 years old.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394000


Locations
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Belgium
Jessa hospital
Hasselt, Belgium, 3500
Sponsors and Collaborators
Jessa Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jessa Hospital
ClinicalTrials.gov Identifier: NCT04394000    
Other Study ID Numbers: Jessa_20.48
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases