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Trial Outcomes & Findings for Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients (NCT NCT02412982)

NCT ID: NCT02412982

Last Updated: 2021-10-25

Results Overview

Serum AT-III (% activity) will be compared between the control group and the intervention group patients (combined) after the third dose of enoxaparin 30 mg every 12 hours once initiated at the discretion of the trauma service per current VTE prophylaxis protocol

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

103 participants

Primary outcome timeframe

After third dose of enoxaparin 30mg q12h, which will typically be on Day 2 of enoxaparin

Results posted on

2021-10-25

Participant Flow

1496 screened for eligibility. 1393 excluded. 51 in control group (anti-Xa 0.1 IU/mL or greater); 52 in intervention group (anti-Xa \< 0.1 IU/mL) 52 patients in the intervention group underwent 1:1 randomization to the two intervention study arms: 26 patients in 40 mg every 12 hours with escalation to 50 mg every 12 hours and 26 patients in 30 mg every 8 hours.

Participant milestones

Participant milestones
Measure
Control Group
Patients with serum anti-Xa level \>= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours n = 51 4 with AT-III not collected so 47 included in primary outcome analysis
Intervention Group
Patients with serum anti-Xa \< 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours n = 52 1 patient withdrew consent; 2 patients did not have AT-III collected. 49 total included in primary outcome analyses.
Primary Endpoint
STARTED
51
52
Primary Endpoint
COMPLETED
47
49
Primary Endpoint
NOT COMPLETED
4
3
Intervention Group: Randomization
STARTED
0
52
Intervention Group: Randomization
COMPLETED
0
51
Intervention Group: Randomization
NOT COMPLETED
0
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control: Serum Anti-Xa >= 0.1 IU/mL
n=47 Participants
Patients with serum anti-Xa level \>= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours
Intervention: Serum Anti-Xa < 0.1 IU/mL
n=51 Participants
Patients with serum anti-Xa level \< 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours
Total
n=98 Participants
Total of all reporting groups
Age, Continuous
Age
38 years
n=47 Participants
41 years
n=51 Participants
41 years
n=98 Participants
Sex: Female, Male
Female
18 Participants
n=47 Participants
13 Participants
n=51 Participants
31 Participants
n=98 Participants
Sex: Female, Male
Male
29 Participants
n=47 Participants
38 Participants
n=51 Participants
67 Participants
n=98 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: After third dose of enoxaparin 30mg q12h, which will typically be on Day 2 of enoxaparin

Serum AT-III (% activity) will be compared between the control group and the intervention group patients (combined) after the third dose of enoxaparin 30 mg every 12 hours once initiated at the discretion of the trauma service per current VTE prophylaxis protocol

Outcome measures

Outcome measures
Measure
Control Group
n=47 Participants
Patients with serum anti-Xa level \>= 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours n = 51 4 with AT-III not collected so 47 included in primary outcome analysis
Intervention Group
n=49 Participants
Patients with serum anti-Xa \< 0.1 IU/mL after third dose of enoxaparin 30 mg every 12 hours n = 52 1 patient withdrew consent; 2 patients did not have AT-III collected. 49 total included in primary outcome analyses.
Initial AT-III Activity -- Control Group vs. Intervention Group Prior to Randomization
87 Percent AT-III activity (%)
Interval 80.0 to 98.0
82 Percent AT-III activity (%)
Interval 71.0 to 96.0

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Molly Droege, PharmD

UC Health - University of Cincinnati Medical Center

Phone: 513-584-2126

Results disclosure agreements

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