Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04508439
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-05
Brief Title:
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Sponsor:
Hospital Regional de Alta especialidad de Ixtapaluca
Organization:
Hospital Regional de Alta especialidad de Ixtapaluca
Study Overview
Official Title:
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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:
Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms Multiple pathogenic mechanisms are involved including endothelial dysfunction increased von Willebrand factor Toll receptor activation and tissue factor pathway activation D-dimer levels greater than 1000 ng mL are associated with an 18-fold increased risk of mortality In this context many patients may require prophylaxis or antithrombotic treatment with low molecular weight heparins Currently there is no validated scheme on the dose and timing of the use of antithrombotic drugs
The study aims to identify the effect of two anticoagulant strategies prophylactic and therapeutic on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care
The study aims to identify the effect of two anticoagulant strategies prophylactic and therapeutic on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care
Detailed Description:
Randomized clinical trial in patients with a confirmed infection by COVID-19 who require hospital treatment and subsequent ambulatory surveillance
Study population Patients with a diagnosis by PCR of COVID 19 over 18 years of age from the High Specialty Hospital of Ixtapaluca who meet the inclusion criteria
Statistic analysis The students T-test was carried out to identify the difference in the means of the quantitative variables between the groups A value of P 005 95 CI will be considered significant For the hypothesis test the chi-square test will be performed considering a p 005 95 CI value to be significant
Study population Patients with a diagnosis by PCR of COVID 19 over 18 years of age from the High Specialty Hospital of Ixtapaluca who meet the inclusion criteria
Statistic analysis The students T-test was carried out to identify the difference in the means of the quantitative variables between the groups A value of P 005 95 CI will be considered significant For the hypothesis test the chi-square test will be performed considering a p 005 95 CI value to be significant
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