Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04520620
Status:
WITHDRAWN
Last Update Posted:
2020-08-20
First Post:
2020-07-22
Brief Title:
Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Evaluation of the Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention in COVID-19 Intensive Unit Care Patients
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
End of the COVID 19 epidemic in the region and decision to participate in a national study on the same subject COVI-DOSE
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COV-ENOX
Brief Summary:
Patients with COVID-19 have special demographic characteristics including thromboembolic risk factors
The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit patient are not described
Finally given the lack of knowledge on the pharmacokineticpharmacodynamic properties of enoxaparin in intensive care unit patients infected with SARS-CoV-2 we propose to conduct a prospective multicenter cohort study to collect the biological data necessary for its study
The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit patient are not described
Finally given the lack of knowledge on the pharmacokineticpharmacodynamic properties of enoxaparin in intensive care unit patients infected with SARS-CoV-2 we propose to conduct a prospective multicenter cohort study to collect the biological data necessary for its study
Detailed Description:
D-dimers greater than 1 μgmL are a prognostic factor for 28-day mortality odds ratio18 2-128 The use of preventive doses of enoxaparin 4000 to 6000 anti-Xa per day or unfractionated heparin 10000 to 15000 IU per day has been associated with a reduction in mortality of approximately one-third in patients with D-dimer levels greater than 3 μgmL or those with sepsis-induced coagulopathy SIC sepsis-induced coagulopathy score 4
For the intensive care unit patient the preventive enoxaparin dosages were increased to 4000 anti-Xa IU twice daily and to 6000 anti-Xa IU twice daily if the patient weighs more than 120 kg Curative treatment is even proposed in cases of marked inflammatory syndrome andor hypercoagulability eg fibrinogen 8 gL or D-Dimer 3 μgmL or 3000 ngmL even without symptomatic thrombosis
Given the lack of data on the use of these high prophylactic doses of enoxaparin it is proposed that anti-Xa activity be monitored after the 3rd injection and then regularly in the event of renal failure because LMWHs are renally eliminated to look for overdosage exposing a higher risk of bleeding It is also proposed to regularly monitor at least every 48 hours the hemostasis of patients in search of multivisceral failure or of coagulopathy of consumption which will require a re-evaluation of the heparin therapy dosage these events being associated with an increased risk of haemorrhage
For the intensive care unit patient the preventive enoxaparin dosages were increased to 4000 anti-Xa IU twice daily and to 6000 anti-Xa IU twice daily if the patient weighs more than 120 kg Curative treatment is even proposed in cases of marked inflammatory syndrome andor hypercoagulability eg fibrinogen 8 gL or D-Dimer 3 μgmL or 3000 ngmL even without symptomatic thrombosis
Given the lack of data on the use of these high prophylactic doses of enoxaparin it is proposed that anti-Xa activity be monitored after the 3rd injection and then regularly in the event of renal failure because LMWHs are renally eliminated to look for overdosage exposing a higher risk of bleeding It is also proposed to regularly monitor at least every 48 hours the hemostasis of patients in search of multivisceral failure or of coagulopathy of consumption which will require a re-evaluation of the heparin therapy dosage these events being associated with an increased risk of haemorrhage
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001823-15 | EUDRACT_NUMBER | None | None |