Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02774265
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2016-05-10
Brief Title:
A Different Approach to Preventing Thrombosis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Different Approach to Preventing Thrombosis ADAPT A Randomized Controlled Trial Comparing Low Molecular Weight Heparin to Acetylsalicylic Acid in Orthopedic Trauma Patients
Status:
COMPLETED
Status Verified Date:
2022-01
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:
ADAPT
Brief Summary:
The purpose of this study is to perform a pragmatic randomized controlled trial to compare the use of low molecular weight heparin LMWH lovenox enoxaparin versus acetylsalicylic acid ASA for venous thromboembolism VTE prophylaxis in patients with high-risk lower extremity fractures
Detailed Description:
Purpose
To perform a pragmatic randomized controlled trial of the use of low molecular weight heparin LMWH enoxaparin lovenox versus Aspirin ASA for VTE prophylaxis in patients with high-risk extremity fractures
Specific Aims
1 To compare the bleeding complication outcomes associated with LMWH versus ASA in patients receiving VTE prophylaxis following high-risk lower extremity fractures
2 To compare the incidence of clinically important VTE events associated with LMWH versus ASA for VTE prophylaxis in patients receiving VTE prophylaxis following high-risk lower extremity fractures
3 To compare the 6-month treatment costs associated with VTE prophylaxis using either LMWH or ASA for high-risk lower extremity fracture patients
Hypothesis
1 Among patients with high risk lower extremity fractures receiving VTE prophylaxis the rate of bleeding complications will be lower for patients receiving ASA compared to those receiving LMWH
2 Among patients with high risk lower extremity fractures receiving VTE prophylaxis the rate of VTE for patients receiving ASA will be no greater than those receiving LMWH
3 Among patients with high risk lower extremity fractures receiving VTE prophylaxis the 6-month treatment costs will be lower for patients receiving ASA compared to those receiving LMWH
MethodsOutcomes
A randomized controlled trial will be conducted to assess the use of LMWH versus ASA for VTE prophylaxis in patients with high-risk extremity fractures
The aim-specific outcomes to be collected are as follows
1 A composite of the following major bleeding related complications
1 Fatal bleeding into a critical organ retroperitoneal intracranial intraocular intraspinal
2 Clinically overt bleed with a 2gdL drop in Hb or requiring 2U transfusion
3 Wound drainage or hematoma requiring reoperation
4 Diagnosis of deep surgical site infection
2 VTE Events defined as a composite of any symptomatic proximal DVT in the femoral or popliteal vessels or PE central segmental or subsegmental All VTE events will be confirmed using multiplanar CT scan or formal venous duplex exam
3 Cost of VTE prophylaxis treatment VTE events and bleeding related complications
Data Collection
Patients meeting inclusionexclusion criteria will be prospectively randomized to one of two treatment arms Block randomization will be used Patients will receive VTE prophylaxis as allocated and followed for their index hospitalization and a 3month period post discharge for VTE events and bleeding complications Outcome data will be prospectively collected during index hospitalization and at 2 weeks and 3 months post discharge and blind analysis and interpretation of results will be performed at 50 and 100 recruitment
Data Analysis
All data will be reported as mean and standard deviations for continuous variables and proportions and percentages for categorical data Kaplan-Meier survival and Cox proportional hazard analysis will be completed for time to VTE and bleeding complication outcomes Sub-group analysis will include Injury Severity Score and fracture location An independent Data Safety and Monitoring Committee will complete interim analysis at 50 recruitment A cost analysis will be conducted using a 6month and lifetime time horizon with a societal perspective Component costs will consist of VTE prophylaxis costs unscheduled follow-ups emergency room visit hospital admission or unscheduled repeat surgical intervention for VTE or bleeding complications
Study Treatment Arms
1 VTE prophylaxis with Enoxaparin 30mg SC BID
2 VTE prophylaxis with ASA 81mg PO BID
To perform a pragmatic randomized controlled trial of the use of low molecular weight heparin LMWH enoxaparin lovenox versus Aspirin ASA for VTE prophylaxis in patients with high-risk extremity fractures
Specific Aims
1 To compare the bleeding complication outcomes associated with LMWH versus ASA in patients receiving VTE prophylaxis following high-risk lower extremity fractures
2 To compare the incidence of clinically important VTE events associated with LMWH versus ASA for VTE prophylaxis in patients receiving VTE prophylaxis following high-risk lower extremity fractures
3 To compare the 6-month treatment costs associated with VTE prophylaxis using either LMWH or ASA for high-risk lower extremity fracture patients
Hypothesis
1 Among patients with high risk lower extremity fractures receiving VTE prophylaxis the rate of bleeding complications will be lower for patients receiving ASA compared to those receiving LMWH
2 Among patients with high risk lower extremity fractures receiving VTE prophylaxis the rate of VTE for patients receiving ASA will be no greater than those receiving LMWH
3 Among patients with high risk lower extremity fractures receiving VTE prophylaxis the 6-month treatment costs will be lower for patients receiving ASA compared to those receiving LMWH
MethodsOutcomes
A randomized controlled trial will be conducted to assess the use of LMWH versus ASA for VTE prophylaxis in patients with high-risk extremity fractures
The aim-specific outcomes to be collected are as follows
1 A composite of the following major bleeding related complications
1 Fatal bleeding into a critical organ retroperitoneal intracranial intraocular intraspinal
2 Clinically overt bleed with a 2gdL drop in Hb or requiring 2U transfusion
3 Wound drainage or hematoma requiring reoperation
4 Diagnosis of deep surgical site infection
2 VTE Events defined as a composite of any symptomatic proximal DVT in the femoral or popliteal vessels or PE central segmental or subsegmental All VTE events will be confirmed using multiplanar CT scan or formal venous duplex exam
3 Cost of VTE prophylaxis treatment VTE events and bleeding related complications
Data Collection
Patients meeting inclusionexclusion criteria will be prospectively randomized to one of two treatment arms Block randomization will be used Patients will receive VTE prophylaxis as allocated and followed for their index hospitalization and a 3month period post discharge for VTE events and bleeding complications Outcome data will be prospectively collected during index hospitalization and at 2 weeks and 3 months post discharge and blind analysis and interpretation of results will be performed at 50 and 100 recruitment
Data Analysis
All data will be reported as mean and standard deviations for continuous variables and proportions and percentages for categorical data Kaplan-Meier survival and Cox proportional hazard analysis will be completed for time to VTE and bleeding complication outcomes Sub-group analysis will include Injury Severity Score and fracture location An independent Data Safety and Monitoring Committee will complete interim analysis at 50 recruitment A cost analysis will be conducted using a 6month and lifetime time horizon with a societal perspective Component costs will consist of VTE prophylaxis costs unscheduled follow-ups emergency room visit hospital admission or unscheduled repeat surgical intervention for VTE or bleeding complications
Study Treatment Arms
1 VTE prophylaxis with Enoxaparin 30mg SC BID
2 VTE prophylaxis with ASA 81mg PO BID
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