Trial Outcomes & Findings for Aspirin and Enoxaparin for VTE in Trauma (NCT NCT02396732)

NCT ID: NCT02396732

Last Updated: 2019-11-19

Results Overview

Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: Up to 2 months of hospitalization
• Results posted on: 2019-11-19

Participant Flow

Participant milestones

Measure	LMWH + ASA Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.	LMWH Alone Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
Overall Study STARTED	14	17
Overall Study COMPLETED	14	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin and Enoxaparin for VTE in Trauma

Baseline characteristics by cohort

Measure	LMWH + ASA n=14 Participants Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.	LMWH Alone n=17 Participants Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.	Total n=31 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 13 • n=93 Participants	40 years STANDARD_DEVIATION 16 • n=4 Participants	40 years STANDARD_DEVIATION 14 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic / Latino	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized White	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 2 months of hospitalization

Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan

Outcome measures

Measure	LMWH + ASA n=14 Participants Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.	LMWH Alone n=17 Participants Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
Incidence of Venous Thromboembolism	1 incidents	3 incidents

SECONDARY outcome

Timeframe: Baseline, up to 2 months hospitalization

Population: Data analysis was not completed for this outcome as samples were not collected as per protocol.

Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 months of hospitalization

Mortality will be reported as the number of participants with reported death upon hospital discharge

Outcome measures

Measure	LMWH + ASA n=14 Participants Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.	LMWH Alone n=17 Participants Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
Mortality	0 Participants	1 Participants

Adverse Events

LMWH + ASA

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

LMWH Alone

Serious events: 4 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	LMWH + ASA n=14 participants at risk Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.	LMWH Alone n=17 participants at risk Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
General disorders Altered Mental Status	7.1% 1/14 • Number of events 1 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.	0.00% 0/17 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.
Blood and lymphatic system disorders Venous Thromboembolism	7.1% 1/14 • Number of events 1 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.	17.6% 3/17 • Number of events 3 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.
Blood and lymphatic system disorders Bacteremia	7.1% 1/14 • Number of events 1 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.	23.5% 4/17 • Number of events 4 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.
Respiratory, thoracic and mediastinal disorders Pneumonia	7.1% 1/14 • Number of events 1 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.	5.9% 1/17 • Number of events 1 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.

Other adverse events

Measure	LMWH + ASA n=14 participants at risk Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.	LMWH Alone n=17 participants at risk Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
Renal and urinary disorders Urinary Tract Infection	7.1% 1/14 • Number of events 1 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.	5.9% 1/17 • Number of events 1 • Up to 2 months For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.

Additional Information

Kenneth Proctor

University of Miami

Phone: 305-585-1178

Email: kproctor@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place