Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420667
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2007-01-08
Brief Title:
Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery
Sponsor:
G dAnnunzio University
Organization:
G dAnnunzio University
Study Overview
Official Title:
Effect of Low Molecular Weight Heparin vs Unfractionated Heparin on Bleeding After Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2007-01
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:
Because the impairment of platelet function may cause excess peri-operative bleeding pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery We aimed to evaluate the impact of a low-molecular-weight-heparin LMWH enoxaparin and unfractionated heparin UFH on coagulation parameters and peri-operative bleeding in patients undergoing elective coronary artery bypass grafting CABG surgery after aspirin discontinuation
The specific hypothesis of this study was that a 12 h interval is sufficient not to cause excess peri-operative bleeding and is therefore an optimal compromise between antithrombotic efficacy and haemorrhagic safety
The specific hypothesis of this study was that a 12 h interval is sufficient not to cause excess peri-operative bleeding and is therefore an optimal compromise between antithrombotic efficacy and haemorrhagic safety
Detailed Description:
Since LMWH provide many pharmacokinetic advantages compared with UFH and since they are a valid substitution for UFH in a number of settings such as non-ST elevation acute coronary syndromes and prevention of venous thromboembolism LMWH may provide a useful bridge to revascularization after aspirin discontinuation in patients undergoing CABG surgery Obstacles to the spreading of this practice are mainly the absence of solid evidence of equivalence or superiority as to efficacy in this setting and the proof of equal safety namely the absence of excess bleeding because some studies have suggested an increased number of haemorrhagic complications after LMWH particularly with the use of higher doses This might here be a problem as patients are here generally at high risk of thrombotic events and for this reason need higher doses than for prevention of venous thromboembolism
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