Venous ThromboembolismPhase 3ADAPTNCT02774265
A Different Approach to Preventing Thrombosis
A Phase 3 study testing VTE prophylaxis with Enoxaparin 30mg BID and VTE prophylaxis with Aspirin 81mg BID in people with Venous Thromboembolism and Pulmonary Embolism, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Pulmonary Embolism
- What is being tested?
- VTE prophylaxis with Enoxaparin 30mg BID and VTE prophylaxis with Aspirin 81mg BID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients treated at a level-1 trauma center with any one or more of the following injuries: Pelvis fracture (operative or non-operative), Acetabulum fracture (operative or non-operative), or any operative extremity fracture (proximal to metatarsals/carpals)
- Age greater than or equal to 18 years old
Who cannot join
- Patients receiving pre-existing confounding prophylaxis or therapeutic anticoagulation (not to include anti-platelet agents) prior to admission or those receiving greater than one dose of LMWH since injury
- Patients with pre-existing coagulopathy
- Patients with a previous history of VTE within the last 6 months
- Patients who are pregnant
- Patients with CNS or spinal cord injury with potential need for further neurosurgical intervention precluding anticoagulation with aspirin
- Patients with active bleeding precluding the use of anticoagulation
Show all 13Show fewer
- Impaired creatinine clearance <30ml/min at the time of randomization
- History of Heparin Induced Thrombocytopenia or ASA or NSAID allergy
- Prisoners
- Non-english speaking patients
- Patients who have an indication for therapeutic anticoagulation
- Patients deemed inappropriate for inclusion in the study by their treating physician. Reason must be documented
- Patients who would not normally receive VTE prophylaxis for their injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
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
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.
Read the 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:
- To compare the bleeding complication outcomes associated with LMWH versus ASA in patients receiving VTE prophylaxis following high-risk lower extremity fractures.
- 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.
- To compare the 6-month treatment costs associated with VTE prophylaxis using either LMWH or ASA for high-risk lower extremity fracture patients
Hypothesis:
- 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.
- 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.
- 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.
Methods/Outcomes:
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:
- A composite of the following major bleeding related complications:
- Fatal bleeding into a critical organ (retroperitoneal, intracranial, intraocular, intraspinal)
- Clinically overt bleed with a > 2g/dL drop in Hb or requiring > 2U transfusion
- Wound drainage or hematoma requiring reoperation
- Diagnosis of deep surgical site infection
- 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.
- Cost of VTE prophylaxis treatment, VTE events and bleeding related complications.
Data Collection:
Patients meeting inclusion/exclusion 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:
- VTE prophylaxis with Enoxaparin 30mg SC BID
- VTE prophylaxis with ASA 81mg PO BID
- Conditions
- Venous Thromboembolism, Pulmonary Embolism
- Being tested
- VTE prophylaxis with Enoxaparin 30mg BID, VTE prophylaxis with Aspirin 81mg BID
- Keywords
- Fracture, Prophylaxis
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTE prophylaxis with Enoxaparin 30mg BIDDrug
Also called Lovenox, Low Molecular Weight Heparin (LMWH)
Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
VTE prophylaxis with Aspirin 81mg BIDDrug
Also called ASA (Acetylsalicylic Acid)
Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
| Study group | Role | What they receive |
|---|---|---|
| VTE prophylaxis with Enoxaparin 30mg BID | Active comparator | The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID. Receives: Drug: VTE prophylaxis with Enoxaparin 30mg BID |
| VTE prophylaxis with Aspirin 81mg BID | Active comparator | The group receiving VTE prophylaxis with ASA 81mg PO BID Receives: Drug: VTE prophylaxis with Aspirin 81mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.
Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed
Measured: 90 days
Secondary outcomes (2)
Number of Participants With Deep Venous Thromboembolism
DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy.
Measured: 90 days
Number of Participants With Pulmonary Embolism Events
Bases on imaging obtained for symptoms.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Stein, University of Maryland, Baltimore
- Investigators
- Deborah Stein, MD, MPH, Principal investigator, R. Adams Cowley Shock Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774265
- Sponsor's protocol ID
- HP-00065750
- Acronym
- ADAPT
- Status last verified
- Jan 2022
- First submitted
- 10 May 2016
- Last updated
- 5 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be shared as aggregate data only to protect the identity of individual participants.
Publications
Cohen AT, Imfeld S, Markham J, Granziera S. The use of aspirin for primary and secondary prevention in venous thromboembolism and other cardiovascular disorders. Thromb Res. 2015 Feb;135(2):217-25. doi: 10.1016/j.thromres.2014.11.036. Epub 2014 Dec 13.
PubMed 25541030Selby R, Geerts WH, Kreder HJ, Crowther MA, Kaus L, Sealey F; D-KAF (Dalteparin in Knee-to-Ankle Fracture) Investigators. A double-blind, randomized controlled trial of the prevention of clinically important venous thromboembolism after isolated lower leg fractures. J Orthop Trauma. 2015 May;29(5):224-30. doi: 10.1097/BOT.0000000000000250.
PubMed 25900749Scolaro JA, Taylor RM, Wigner NA. Venous thromboembolism in orthopaedic trauma. J Am Acad Orthop Surg. 2015 Jan;23(1):1-6. doi: 10.5435/JAAOS-23-01-1.
PubMed 25538125Gritsiouk Y, Hegsted DA, Schlesinger P, Gardiner SK, Gubler KD. A retrospective analysis of the effectiveness of low molecular weight heparin for venous thromboembolism prophylaxis in trauma patients. Am J Surg. 2014 May;207(5):648-51; discussion 651-2. doi: 10.1016/j.amjsurg.2013.12.010. Epub 2014 Jan 30.
PubMed 24560359Schousboe JT, Brown GA. Cost-effectiveness of low-molecular-weight heparin compared with aspirin for prophylaxis against venous thromboembolism after total joint arthroplasty. J Bone Joint Surg Am. 2013 Jul 17;95(14):1256-64. doi: 10.2106/JBJS.L.00400.
PubMed 23864173Lieberman JR, Pensak MJ. Prevention of venous thromboembolic disease after total hip and knee arthroplasty. J Bone Joint Surg Am. 2013 Oct 2;95(19):1801-11. doi: 10.2106/JBJS.L.01328.
PubMed 24088973Mortazavi SM, Hansen P, Zmistowski B, Kane PW, Restrepo C, Parvizi J. Hematoma following primary total hip arthroplasty: a grave complication. J Arthroplasty. 2013 Mar;28(3):498-503. doi: 10.1016/j.arth.2012.07.033. Epub 2012 Oct 31.
PubMed 23122656Brakenridge SC, Henley SS, Kashner TM, Golden RM, Paik DH, Phelan HA, Cohen MJ, Sperry JL, Moore EE, Minei JP, Maier RV, Cuschieri J; Inflammation and the Host Response to Injury Investigators. Comparing clinical predictors of deep venous thrombosis versus pulmonary embolus after severe injury: a new paradigm for posttraumatic venous thromboembolism? J Trauma Acute Care Surg. 2013 May;74(5):1231-7; discussion 1237-8. doi: 10.1097/TA.0b013e31828cc9a0.
PubMed 23609272Sagi HC, Dziadosz D, Mir H, Virani N, Olson C. Obesity, leukocytosis, embolization, and injury severity increase the risk for deep postoperative wound infection after pelvic and acetabular surgery. J Orthop Trauma. 2013 Jan;27(1):6-10. doi: 10.1097/BOT.0b013e31825cf382.
PubMed 23263468Raphael IJ, Tischler EH, Huang R, Rothman RH, Hozack WJ, Parvizi J. Aspirin: an alternative for pulmonary embolism prophylaxis after arthroplasty? Clin Orthop Relat Res. 2014 Feb;472(2):482-8. doi: 10.1007/s11999-013-3135-z.
PubMed 23817755Stewart DW, Freshour JE. Aspirin for the prophylaxis of venous thromboembolic events in orthopedic surgery patients: a comparison of the AAOS and ACCP guidelines with review of the evidence. Ann Pharmacother. 2013 Jan;47(1):63-74. doi: 10.1345/aph.1R331. Epub 2013 Jan 16.
PubMed 23324504Anderson DR, Dunbar MJ, Bohm ER, Belzile E, Kahn SR, Zukor D, Fisher W, Gofton W, Gross P, Pelet S, Crowther M, MacDonald S, Kim P, Pleasance S, Davis N, Andreou P, Wells P, Kovacs M, Rodger MA, Ramsay T, Carrier M, Vendittoli PA. Aspirin versus low-molecular-weight heparin for extended venous thromboembolism prophylaxis after total hip arthroplasty: a randomized trial. Ann Intern Med. 2013 Jun 4;158(11):800-6. doi: 10.7326/0003-4819-158-11-201306040-00004.
PubMed 23732713Cossetto DJ, Goudar A, Parkinson K. Safety of peri-operative low-dose aspirin as a part of multimodal venous thromboembolic prophylaxis for total knee and hip arthroplasty. J Orthop Surg (Hong Kong). 2012 Dec;20(3):341-3. doi: 10.1177/230949901202000315.
PubMed 23255642Vulcano E, Gesell M, Esposito A, Ma Y, Memtsoudis SG, Gonzalez Della Valle A. Aspirin for elective hip and knee arthroplasty: a multimodal thromboprophylaxis protocol. Int Orthop. 2012 Oct;36(10):1995-2002. doi: 10.1007/s00264-012-1588-4. Epub 2012 Jun 12.
PubMed 22684546Mont MA, Jacobs JJ. AAOS clinical practice guideline: preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Am Acad Orthop Surg. 2011 Dec;19(12):777-8. doi: 10.5435/00124635-201112000-00008. No abstract available.
PubMed 22134210
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02774265
- Acronym / sponsor ID
- ADAPT / HP-00065750
- Conditions
- Venous Thromboembolism, Pulmonary Embolism
- Keywords
- Fracture, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 24 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the bleeding complication outcomes associated with LMWH versus ASA in patients receiving VTE prophylaxis following high-risk lower extremity fractures.
- 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.
- To compare the 6-month treatment costs associated with VTE prophylaxis using either LMWH or ASA for high-risk lower extremity fracture patients
Hypothesis:
- 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.
- 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.
- 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.
Methods/Outcomes:
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:
- A composite of the following major bleeding related complications:
- Fatal bleeding into a critical organ (retroperitoneal, intracranial, intraocular, intraspinal)
- Clinically overt bleed with a > 2g/dL drop in Hb or requiring > 2U transfusion
- Wound drainage or hematoma requiring reoperation
- Diagnosis of deep surgical site infection
- 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.
- Cost of VTE prophylaxis treatment, VTE events and bleeding related complications.
Data Collection:
Patients meeting inclusion/exclusion 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:
- VTE prophylaxis with Enoxaparin 30mg SC BID
- VTE prophylaxis with ASA 81mg PO BID
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VTE prophylaxis with Enoxaparin 30mg BID | Active comparator | Drug: VTE prophylaxis with Enoxaparin 30mg BIDThe group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID. |
| VTE prophylaxis with Aspirin 81mg BID | Active comparator | Drug: VTE prophylaxis with Aspirin 81mg BIDThe group receiving VTE prophylaxis with ASA 81mg PO BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients treated at a level-1 trauma center with any one or more of the following injuries: Pelvis fracture (operative or non-operative), Acetabulum fracture (operative or non-operative), or any operative extremity fracture (proximal to metatarsals/carpals)
- Age greater than or equal to 18 years old
Key exclusion criteria (13 listed)
- Patients receiving pre-existing confounding prophylaxis or therapeutic anticoagulation (not to include anti-platelet agents) prior to admission or those receiving greater than one dose of LMWH since injury
- Patients with pre-existing coagulopathy
- Patients with a previous history of VTE within the last 6 months
- Patients who are pregnant
- Patients with CNS or spinal cord injury with potential need for further neurosurgical intervention precluding anticoagulation with aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTE prophylaxis with Enoxaparin 30mg BIDAlso: Lovenox, Low Molecular Weight Heparin (LMWH)Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury. | Drug | VTE prophylaxis with Enoxaparin 30mg BID |
| VTE prophylaxis with Aspirin 81mg BIDAlso: ASA (Acetylsalicylic Acid)Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury. | Drug | VTE prophylaxis with Aspirin 81mg BID |
Primary outcome
Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.
Time frame: 90 days
Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed
2 secondary outcomes
Number of Participants With Deep Venous Thromboembolism
Time frame: 90 days
Number of Participants With Pulmonary Embolism Events
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25541030Cohen AT, Imfeld S, Markham J, Granziera S. The use of aspirin for primary and secondary prevention in venous thromboembolism and other cardiovascular disorders. Thromb Res. 2015 Feb;135(2):217-25. doi: 10.1016/j.thromres.2014.11.036. Epub 2014 Dec 13.
- Background: PubMed 25900749Selby R, Geerts WH, Kreder HJ, Crowther MA, Kaus L, Sealey F; D-KAF (Dalteparin in Knee-to-Ankle Fracture) Investigators. A double-blind, randomized controlled trial of the prevention of clinically important venous thromboembolism after isolated lower leg fractures. J Orthop Trauma. 2015 May;29(5):224-30. doi: 10.1097/BOT.0000000000000250.
- Background: PubMed 25538125Scolaro JA, Taylor RM, Wigner NA. Venous thromboembolism in orthopaedic trauma. J Am Acad Orthop Surg. 2015 Jan;23(1):1-6. doi: 10.5435/JAAOS-23-01-1.
- Background: PubMed 24560359Gritsiouk Y, Hegsted DA, Schlesinger P, Gardiner SK, Gubler KD. A retrospective analysis of the effectiveness of low molecular weight heparin for venous thromboembolism prophylaxis in trauma patients. Am J Surg. 2014 May;207(5):648-51; discussion 651-2. doi: 10.1016/j.amjsurg.2013.12.010. Epub 2014 Jan 30.
- Background: PubMed 23864173Schousboe JT, Brown GA. Cost-effectiveness of low-molecular-weight heparin compared with aspirin for prophylaxis against venous thromboembolism after total joint arthroplasty. J Bone Joint Surg Am. 2013 Jul 17;95(14):1256-64. doi: 10.2106/JBJS.L.00400.
- Background: PubMed 24088973Lieberman JR, Pensak MJ. Prevention of venous thromboembolic disease after total hip and knee arthroplasty. J Bone Joint Surg Am. 2013 Oct 2;95(19):1801-11. doi: 10.2106/JBJS.L.01328.
- Background: PubMed 23122656Mortazavi SM, Hansen P, Zmistowski B, Kane PW, Restrepo C, Parvizi J. Hematoma following primary total hip arthroplasty: a grave complication. J Arthroplasty. 2013 Mar;28(3):498-503. doi: 10.1016/j.arth.2012.07.033. Epub 2012 Oct 31.
- Background: PubMed 23609272Brakenridge SC, Henley SS, Kashner TM, Golden RM, Paik DH, Phelan HA, Cohen MJ, Sperry JL, Moore EE, Minei JP, Maier RV, Cuschieri J; Inflammation and the Host Response to Injury Investigators. Comparing clinical predictors of deep venous thrombosis versus pulmonary embolus after severe injury: a new paradigm for posttraumatic venous thromboembolism? J Trauma Acute Care Surg. 2013 May;74(5):1231-7; discussion 1237-8. doi: 10.1097/TA.0b013e31828cc9a0.
- Background: PubMed 23263468Sagi HC, Dziadosz D, Mir H, Virani N, Olson C. Obesity, leukocytosis, embolization, and injury severity increase the risk for deep postoperative wound infection after pelvic and acetabular surgery. J Orthop Trauma. 2013 Jan;27(1):6-10. doi: 10.1097/BOT.0b013e31825cf382.
- Background: PubMed 23817755Raphael IJ, Tischler EH, Huang R, Rothman RH, Hozack WJ, Parvizi J. Aspirin: an alternative for pulmonary embolism prophylaxis after arthroplasty? Clin Orthop Relat Res. 2014 Feb;472(2):482-8. doi: 10.1007/s11999-013-3135-z.
- Background: PubMed 23324504Stewart DW, Freshour JE. Aspirin for the prophylaxis of venous thromboembolic events in orthopedic surgery patients: a comparison of the AAOS and ACCP guidelines with review of the evidence. Ann Pharmacother. 2013 Jan;47(1):63-74. doi: 10.1345/aph.1R331. Epub 2013 Jan 16.
- Background: PubMed 23732713Anderson DR, Dunbar MJ, Bohm ER, Belzile E, Kahn SR, Zukor D, Fisher W, Gofton W, Gross P, Pelet S, Crowther M, MacDonald S, Kim P, Pleasance S, Davis N, Andreou P, Wells P, Kovacs M, Rodger MA, Ramsay T, Carrier M, Vendittoli PA. Aspirin versus low-molecular-weight heparin for extended venous thromboembolism prophylaxis after total hip arthroplasty: a randomized trial. Ann Intern Med. 2013 Jun 4;158(11):800-6. doi: 10.7326/0003-4819-158-11-201306040-00004.
- Individual participant dataSharing planned: No. Data will be shared as aggregate data only to protect the identity of individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Stein, MD, MPH principal investigator
R. Adams Cowley Shock Trauma Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VTE prophylaxis with Enoxaparin 30mg BID and VTE prophylaxis with Aspirin 81mg BID in people with Venous Thromboembolism and Pulmonary Embolism, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774265, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.