Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients

NCT04412304 — Completed, 166 participants, Karolinska Institutet

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden

Registry	NCT04412304
Status	Completed
Study type	Observational
Enrollment	166 (Actual)
Sponsor	Karolinska Institutet (Other)
Conditions	Covid-19, Thromboembolic Events, Bleeding
Interventions	Dose of Tinzaparin or Dalteparin (Drug)
Dates	start 2020-03-06, primary completion 2020-04-30, completion 2020-05-28, first posted 2020-06-02, last updated 2020-06-22
Locations	1 site in Sweden

-Summary

The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.

Expand all sections · Collapse all

+Arms and interventions

Arm	Interventions	Description
thrombose prophylaxis	Drug: Dose of Tinzaparin or Dalteparin	The dose used to prevent thromboembolic complication in critically ill
double thrombose prophylaxis	Drug: Dose of Tinzaparin or Dalteparin	Double the dose used to prevent thromboembolic complication in critically ill
full dose anticoagulant	Drug: Dose of Tinzaparin or Dalteparin	Dose used to treat thromboembolic event

Dose of Tinzaparin or Dalteparin (Drug): The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.

+Outcome measures

Primary outcomes

28-days ICU mortality [28 days from ICU-admission]: 28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.

Secondary outcomes

Incidence of thromboembolic events [28 days from ICU-admission]: Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT), ischemic stroke and other peripheral arterial emboli. 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. Peripheral arterial emboli are defined as peripheral arterial emboli verified by computer tomography.
Incidence of bleeding events [28 days from ICU-admission]: The event of bleeding will be defined by WHO modified bleeding scale as 1-4.
ICU-free days alive from ICU-admission. [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.

Other outcomes

D-dimer levels in the three groups groups [28 days from ICU-admission]: D-dimer every day it is measured during first 28 days from ICU-admission.

+Eligibility

Sex: All

Inclusion Criteria:

* laboratory confirmed positive test for SARS-CoV-2
* admitted to ICU because of critical illness due to 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 or the following day as ICU admission

+Locations (1)

Facility	City	Country	Status
South General Hospital	Stockholm, Stockholm County	Sweden

+Publications

Results publication: Jonmarker S, Hollenberg J, Dahlberg M, Stackelberg O, Litorell J, Everhov AH, Jarnbert-Pettersson H, Soderberg M, Grip J, Schandl A, Gunther M, Cronhjort M. Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients. Crit Care. 2020 Nov 23;24(1):653. doi: 10.1186/s13054-020-03375-7. PMID 33225952

+Investigators

Maria Cronhjort, PhD, Principal investigator, Karolinska Institutet, Department of Clinical Science and Education