Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351663
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2006-07-12
Brief Title:
The Effect of Vasopressors on the Anti Xa Response to Enoxaparin in Critically Ill Patients
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Prospective Randomised Study of the Effect of Vasopressors on the Anti Xa Response to Enoxaparin in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2016-04
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 purpose of this study is to evaluate the efficacy of 3 different dosing regimens of enoxaparin in achieving adequate antithrombotic aFXa levels in critically ill patients
The relationship between appearance of DVT and antithrombotic aFXa levels will also be assessed and risk factors associated with inadequate aFXa levels under standard enoxaparin dosages will be searched for
The relationship between appearance of DVT and antithrombotic aFXa levels will also be assessed and risk factors associated with inadequate aFXa levels under standard enoxaparin dosages will be searched for
Detailed Description:
Critically ill patients are at increased risk of venous thrombosis and embolism from DVT Low molecular weigh heparins such as enoxaparin clexane have more favorable pharmacokinetic pharmacodynamic profiles equivalent or improved efficacy eg in post trauma and orthopedic surgery patients and fewer bleeding complications than low-dose unfractionated heparin These medications are currently recommended for DVT prophylaxis in critically ill patients and are usually administered subcutaneously SQ The antithrombotic activity of LMWHs correlates with peak aFXa levels However the the appropriate dose and dosing interval of enoxaparin for DVT prophylaxis in critically ill surgical patients has not been established and in particular remains unknown for those patients with severe peripheral edema ansor decreased peripheral circulation due to therapy with vasopressors Several studies have recently demonstrated questionable efficacy of standard daily enoxaparin dosing for critically ill patients as DVT prophylaxis
The current study will be a prospective randomized cohort study conducted at the Shaare Zedek Medical Center over a period of 1 year 100 patients All critically ill patients aged 18 years with a predicted requirement of mechanical ventilation for 3 days will be included Data collection will be performed anonymously and will include patient demographics and admission details duplex monitoring for DVT and daily recording of APACHE II scores renal function coagulation profile and overall dose of vasopressors
Patients will be randomized to receive enoxaparin in accordance three DVT prophylaxis protocols- IV by weight SQ by weight or SQ 40mg x1day standard Blood samples for the evaluation of aFXa will be drawn twice daily for peak and trough activity over a period of 5 days No further changes will be made in the standard therapy Patient outcomes and occurrence of adverse events will be recorded The principle outcome variable will be achievement of target peak and trough levels of aFXa during the 5 day study period
The current study will be a prospective randomized cohort study conducted at the Shaare Zedek Medical Center over a period of 1 year 100 patients All critically ill patients aged 18 years with a predicted requirement of mechanical ventilation for 3 days will be included Data collection will be performed anonymously and will include patient demographics and admission details duplex monitoring for DVT and daily recording of APACHE II scores renal function coagulation profile and overall dose of vasopressors
Patients will be randomized to receive enoxaparin in accordance three DVT prophylaxis protocols- IV by weight SQ by weight or SQ 40mg x1day standard Blood samples for the evaluation of aFXa will be drawn twice daily for peak and trough activity over a period of 5 days No further changes will be made in the standard therapy Patient outcomes and occurrence of adverse events will be recorded The principle outcome variable will be achievement of target peak and trough levels of aFXa during the 5 day study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None