Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623177
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2020-11-02
Brief Title:
Thromboprophylaxis for Patients in ICU With COVID-19
Sponsor:
Instituto de Investigacion Sanitaria La Fe
Organization:
Instituto de Investigacion Sanitaria La Fe
Study Overview
Official Title:
Effectiveness of Thromboprophylaxis With Low Molecular Weight Heparin in Critically Ill Patients With COVID-19 A Prospective Cohort Multicenter Study
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The respiratory distress that goes with COVID-19 infection has been related to a procoagulant state with thrombosis at both venous and arterial levels that determines hypoxia and tissue dysfunction at several organs The main sign of this thrombotic activity seems to be the D-Dimers that have been proposed to identify patients with poor prognosis at an early stage
Knowledge on how to prevent or even treat this procoagulant state is scarce COVID-19 patients may be out of general thromboprophylaxis recommendations and recent studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with low molecular weight heparin LMWH However the LMWH efficacy and safety mainly in patients admitted to an Intensive Care Unit remains to be validated
Knowledge on how to prevent or even treat this procoagulant state is scarce COVID-19 patients may be out of general thromboprophylaxis recommendations and recent studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with low molecular weight heparin LMWH However the LMWH efficacy and safety mainly in patients admitted to an Intensive Care Unit remains to be validated
Detailed Description:
Many reports have postulated a procoagulant state along with the respiratory distress caused by coronavirus SARS-CoV2 A complex physiopathology has been proposed trying to explain this profile mainly based on the thromboinflammatory concept with thrombosis at both venous and arterial levels Microvascular thrombi impair the blood flow all over the body with a vascular shunt due to capillary obstruction that determines hypoxia and tissue dysfunction at several organs being the lung the more affected one
Although D-Dimers DD are not specific indicators of clot formation its elevation in combination with other parameters hyperfibrinogenemia mild thrombocytopenia may suggest a systemic coagulation activation with an increase of thrombin generation and fibrinolysis In fact in a retrospective Chinese analysis a DD higher than 1000 ngml was proposed to identify patients with poor prognosis at an early stage
Nevertheless knowledge on how to prevent or even treat this procoagulant state is scarce Thromboprophylaxis with low molecular-weight heparin LMWH is recommended in most medical patients admitted to the hospital and in nearly all patients in an Intensive Care Unit ICU But COVID-19 patients may be out of these recommendations and some treatment schemes has been proposed although how to decide the suitable LMWH for each clinical situation is controversial Recent retrospective studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with LMWH However the LMWH efficacy and safety mainly in COVID-19 patients admitted to the ICU remains to be validated
Although D-Dimers DD are not specific indicators of clot formation its elevation in combination with other parameters hyperfibrinogenemia mild thrombocytopenia may suggest a systemic coagulation activation with an increase of thrombin generation and fibrinolysis In fact in a retrospective Chinese analysis a DD higher than 1000 ngml was proposed to identify patients with poor prognosis at an early stage
Nevertheless knowledge on how to prevent or even treat this procoagulant state is scarce Thromboprophylaxis with low molecular-weight heparin LMWH is recommended in most medical patients admitted to the hospital and in nearly all patients in an Intensive Care Unit ICU But COVID-19 patients may be out of these recommendations and some treatment schemes has been proposed although how to decide the suitable LMWH for each clinical situation is controversial Recent retrospective studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with LMWH However the LMWH efficacy and safety mainly in COVID-19 patients admitted to the ICU remains to be validated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None