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Below Knee DVT Study

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ClinicalTrials.gov Identifier: NCT03805672
Recruitment Status : Terminated (Terminated due to low enrollment because of decrease in DVT rates.)
First Posted : January 16, 2019
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Martin A Schreiber, MD, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Deep Vein Thrombosis (DVT)
Blood Clots
Interventions Drug: Low Dose Enoxaparin
Drug: High Dose Enoxaparin
Enrollment 4
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Low Dose Enoxaparin High Dose Enoxaparin
Hide Arm/Group Description

Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.

Low 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

Period Title: Overall Study
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Low Dose Enoxaparin High Dose Enoxaparin Total
Hide Arm/Group Description

Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.

Low 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

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
1
  50.0%
2
  50.0%
>=65 years
1
  50.0%
1
  50.0%
2
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
45.0  (38.2) 59.5  (37.5) 52.3  (32.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
1
  50.0%
0
   0.0%
1
  25.0%
Male
1
  50.0%
2
 100.0%
3
  75.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Deep Vein Thrombosis Resolution
Hide Description Evaluation of DVT resolution
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Enoxaparin High Dose Enoxaparin
Hide Arm/Group Description:

Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.

Low 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 Number of Participants Analyzed 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
2
 100.0%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Enoxaparin High Dose Enoxaparin
Hide Arm/Group Description

Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.

Low 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

All-Cause Mortality
Low Dose Enoxaparin High Dose Enoxaparin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Enoxaparin High Dose Enoxaparin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose Enoxaparin High Dose Enoxaparin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/2 (50.00%)    
Injury, poisoning and procedural complications     
Bleeding at incision site  [1]  0/2 (0.00%)  0 1/2 (50.00%)  1
Indicates events were collected by systematic assessment
[1]
Subject experienced some increased bleeding at the incision site on lower extremity.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Samantha Underwood
Organization: Oregon Health & Science University
Phone: 503-494-8481
EMail: underwos@ohsu.edu
Layout table for additonal information
Responsible Party: Martin A Schreiber, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03805672     History of Changes
Other Study ID Numbers: 9134
First Submitted: January 14, 2015
First Posted: January 16, 2019
Results First Submitted: February 20, 2019
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019