Trial Outcomes & Findings for Below Knee DVT Study (NCT NCT03805672)

NCT ID: NCT03805672

Last Updated: 2019-03-13

Results Overview

Evaluation of DVT resolution

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 4 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2019-03-13

Participant Flow

Patients 18 years or older who were admitted to the trauma or other surgical service and diagnosed during their hospital admission with an isolated distal DVT were invited to participate in the study.

Participant milestones

Measure	Low Dose Enoxaparin Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution. Low Dose Enoxaparin	High Dose Enoxaparin Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution. High Dose Enoxaparin
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Low Dose Enoxaparin n=2 Participants Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution. Low Dose Enoxaparin	High Dose Enoxaparin n=2 Participants Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution. High Dose Enoxaparin	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=2 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=2 Participants	1 Participants n=2 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=2 Participants	1 Participants n=2 Participants	2 Participants n=4 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 38.2 • n=2 Participants	59.5 years STANDARD_DEVIATION 37.5 • n=2 Participants	52.3 years STANDARD_DEVIATION 32.0 • n=4 Participants
Sex: Female, Male Female	1 Participants n=2 Participants	0 Participants n=2 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=2 Participants	2 Participants n=2 Participants	3 Participants n=4 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	2 participants n=2 Participants	4 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks

Evaluation of DVT resolution

Outcome measures

Measure	Low Dose Enoxaparin n=2 Participants Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution. Low Dose Enoxaparin	High Dose Enoxaparin n=2 Participants Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution. High Dose Enoxaparin
Deep Vein Thrombosis Resolution	2 Participants	2 Participants

Adverse Events

Low Dose Enoxaparin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose Enoxaparin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Dose Enoxaparin n=2 participants at risk Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution. Low Dose Enoxaparin	High Dose Enoxaparin n=2 participants at risk Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution. High Dose Enoxaparin
Injury, poisoning and procedural complications Bleeding at incision site	0.00% 0/2 • 6 months	50.0% 1/2 • Number of events 1 • 6 months

Additional Information

Samantha Underwood

Oregon Health & Science University

Phone: 503-494-8481

Email: underwos@ohsu.edu

Results disclosure agreements

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