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

• ClinicalTrials.gov Identifier: NCT04593654
• Recruitment Status: Completed
• First Posted: October 20, 2020
• Last Update Posted: October 20, 2020
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Sandra Jonmarker, Karolinska Institutet

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Covid19; Thromboembolism	Drug: Dose of tinzaparin or dalteparin

Study Design

• Study Type: Observational
• Actual Enrollment: 257 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: August 15, 2020
• Actual Study Completion Date: October 15, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
low dose thromboprophylaxis; Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin	Drug: Dose of tinzaparin or dalteparin; The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU; Other Name: Innohep/Fragmin
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	Drug: Dose of tinzaparin or dalteparin; The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU; Other Name: Innohep/Fragmin
high dose thromboprophylaxis; Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin	Drug: Dose of tinzaparin or dalteparin; The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU; Other Name: Innohep/Fragmin

Outcome Measures

Primary Outcome Measures :

1. 28-day mortality [ Time Frame: 28 days from ICU-admission ]
   28-day mortality from admission to ICU. Discontinue of ICU-care to palliative care counts as death.

Secondary Outcome Measures :

1. Incidence of thromboembolic events [ Time Frame: 28 days from ICU-admission ]
   Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT) and ischemic stroke. PE is defined as PE verified by computer tomography or by findings of acute strain of the right heart on echocardiography combined with a clinical interpretation of the patients deteriorating as a probable PE stated in the medical records. DVT is defined as DVT verified with ultrasound. Ischemic stroke is defined as ischemic stroke verified by computer tomography.
2. Incidence of bleeding events [ Time Frame: 28 days from ICU-admission ]
   The event of bleeding will be defined by WHO modified bleeding scale as 1-4
3. ICU-free days alive from ICU-admission [ Time Frame: 28 days from ICU-admission ]
   ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment.
4. 90-day mortality [ Time Frame: 90 days from ICU-admission ]
   90-day mortality from admission to ICU.

Other Outcome Measures:

1. Fibrin-D-dimer levels [ Time Frame: 28 days from ICU-admission ]
   Median value of Fibrin-D-dimer

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

A cohort study of the critically ill Covid-19 patients admitted to ICU at Södersjukhuset, Stockholm from1st of March to 15 of July

Criteria

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

Contacts and Locations

Locations

Sweden

Södersjukhuset

Stockholm, Sweden, 11883

Sponsors and Collaborators

Karolinska Institutet

Investigators

• Principal Investigator: Sandra Jonmarker, MD; Karolinska Institutet

More Information

• Responsible Party: Sandra Jonmarker, Principal investigator, MD, PhD-student, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT04593654
• Other Study ID Numbers: Thromboprophylaxis COVID-19
• First Posted: October 20, 2020
• Last Update Posted: October 20, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandra Jonmarker, Karolinska Institutet:

Pulmonary embolism; Anticoagulation; Critical Care; Bleeding; Ischemic stroke

Additional relevant MeSH terms:

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action