Venous Thromboembolism Clinical Trial
Official title:
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Verified date | January 2024 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60% without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa) levels. Outcomes will include peak and trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus, this study has important implications for appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the substantial morbidity and mortality associated with post-operative VTE.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 29, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Receiving orthopedic trauma surgery - Able to have enoxaparin initiated within 36 hours after procedure Exclusion Criteria: - Intracranial bleeding/stroke - bleeding disorder - heparin-induced thrombocytopenia - creatinine clearance < 30 mL/minute - epidural catheter - serum creatinine > 1.6 mg/dL |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Venous Thromboembolism Events | Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery | 90 days | |
Primary | Number of Participants With Bleeding Events | Bleeding events requiring alteration in the course of care within 90 days of surgery | 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05347550 -
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
|
N/A | |
Enrolling by invitation |
NCT05794165 -
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
|
Phase 2 | |
Completed |
NCT02379806 -
The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study
|
Phase 3 | |
Recruiting |
NCT03691753 -
Safety and Efficacy Study of Fitaya Vena Cava Filter
|
N/A | |
Completed |
NCT02197416 -
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
|
Phase 3 | |
Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
Completed |
NCT01895777 -
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
|
Phase 3 | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Completed |
NCT04736420 -
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT04735523 -
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT04736719 -
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT02912234 -
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
|
Phase 1 | |
Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
Completed |
NCT02829957 -
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
|
Phase 2/Phase 3 | |
Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT02661568 -
Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)
|
N/A | |
Completed |
NCT02223260 -
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
|
Phase 2 | |
Completed |
NCT01976988 -
Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery
|
Phase 3 | |
Completed |
NCT01972243 -
Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model
|