Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients

NCT ID: NCT04593654

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-10-15

Brief Summary

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The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.

Detailed Description

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Conditions

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Covid19 Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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low dose thromboprophylaxis

Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin

Dose of tinzaparin or dalteparin

Intervention Type DRUG

The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU

medium dose thromboprophylaxis

Daily dose of \>4500 IU but \<175 IU/kg of body weight tinzaparin or \>5000 IU but \<200 IU/kg of body weight dalteparin

Dose of tinzaparin or dalteparin

Intervention Type DRUG

The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU

high dose thromboprophylaxis

Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin

Dose of tinzaparin or dalteparin

Intervention Type DRUG

The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU

Interventions

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Dose of tinzaparin or dalteparin

The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU

Intervention Type DRUG

Other Intervention Names

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Innohep/Fragmin

Eligibility Criteria

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Inclusion Criteria

* laboratory confirmed positive test for SARS-CoV-2
* admitted to ICU because of respiratory failure caused by Covid-19

Exclusion Criteria

* patients with treatment for thromboembolic complications at arrival to the ICU
* short ICU length of stay defined as discharged the same date as ICU admission
* patients without initial thromboprophylaxis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Sandra Jonmarker

Principal investigator, MD, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra Jonmarker, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Södersjukhuset

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Jonmarker S, Litorell J, Dahlberg M, Stackelberg O, Everhov AH, Soderberg M, Rubenson-Wahlin R, Gunther M, Martensson J, Hollenberg J, Joelsson-Alm E, Cronhjort M. An observational study of intermediate- or high-dose thromboprophylaxis for critically ill COVID-19 patients. Acta Anaesthesiol Scand. 2022 Mar;66(3):365-374. doi: 10.1111/aas.14013. Epub 2021 Dec 16.

Reference Type DERIVED
PMID: 34875111 (View on PubMed)

Other Identifiers

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Thromboprophylaxis COVID-19

Identifier Type: -

Identifier Source: org_study_id

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