Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Below Knee DVT Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 14, 2015
First Posted Date  ICMJE January 16, 2019
Results First Submitted Date  ICMJE February 20, 2019
Results First Posted Date  ICMJE March 13, 2019
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE September 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Deep Vein Thrombosis Resolution [ Time Frame: 6 weeks ]
Evaluation of DVT resolution
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
DVT resolution [ Time Frame: 6 weeks ]
Evaluation of DVT resolution
Change History Complete list of historical versions of study NCT03805672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Below Knee DVT Study
Official Title  ICMJE Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial
Brief Summary

Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths.

It is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. In this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood thinner. We will then see if low dose blood thinner has similar results as high dose blood thinner.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Deep Vein Thrombosis (DVT)
  • Blood Clots
Intervention  ICMJE
  • Drug: Low Dose Enoxaparin
    Other Name: Lovenox
  • Drug: High Dose Enoxaparin
    Other Name: Lovenox
Study Arms  ICMJE
  • Active Comparator: Low Dose Enoxaparin
    Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.
    Intervention: Drug: Low Dose Enoxaparin
  • Active Comparator: 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.
    Intervention: Drug: High Dose Enoxaparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 11, 2019)
4
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients over the age of 18 admitted to a trauma or general surgery service will be eligible
  • Patients diagnosed with an isolated distal DVT
  • Able to obtain informed consent

Exclusion Criteria:

  • Patients with a previous diagnosis of hypercoagulability
  • Patients on chronic anticoagulation
  • Patients with a history of heparin induced thrombocytopenia
  • Patients have preexisting contraindications to anticoagulation
  • Patients in renal failure requiring adjusted enoxaparin dosing
  • Pregnant patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03805672
Other Study ID Numbers  ICMJE 9134
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin A Schreiber, MD, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Schreiber, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP