Recruiting

LMWH

Sponsor:

University of Tennessee

Code:

NCT01029821

Conditions

Deep Venous Thrombosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Low-Molecular-Weight Heparin

Study Details

Brief summary:

1. The use of LMWH following open reduction and internal fixation of ankle fractures will reduce the number of thrombi formed.
2. The rates of clinically significant DVT will be equivalent between two groups.

Conditions

Deep Venous Thrombosis

Study ID

NCT01029821

Start date

Feb, 2010

Status verified date

Jun, 2011

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • At least 18 years old
  • Surgical ankle fracture able to be definitively treated with one operation

Exclusion Criteria:

  • Younger than 18 years of age
  • Other significant injury
  • Known hypercoagulable state
  • History of bleeding disorder
  • History of DVT

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Low-Molecular-Weight Heparin for DVT

Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures

Interventions

Low-Molecular-Weight Heparin

Isolated Ankle Fracture Single planned operation

Primary outcome measure

  • We will compare the rates of thrombi formation between the two groups. We will record any clinical significant thrombi or complications that arise from thrombi. We will record any complications related to administration of LMWH. [ Time Frame: first post-operative office visit (usually 10-14 days) ]

Central Contacts and Locations

Central contacts

Stan Ragon, M.D.

423-778-9202stanragon@hotmail.com

Elaine Pugh

423-778-5663elaine.pugh@erlanger.org

Locations

Erlanger Medical Center

Recruiting

Chattanooga,, Tennessee, United States, 37403

Contacts

Dale Ingram, M.D.

423-266-3719

Stan Ragon, M.D

423-778-9292stanragon@hotmail.com

Principal Investigator:

Dale Ingram, M.D.

More Information

Sponsor

University of Tennessee

Last update posted

Jun 16, 2011

Last verified

Jun, 2011

Keywords

  • Low-Molecular-Weight-Heparin
  • Open Reduction and Internal Fixation
  • Thromboprophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2011-06-16.