Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis

Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01029821

Enrollment

100

Registered

2009-12-10

Start date

2010-02-28

Completion date

2013-12-31

Last updated

2011-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Thrombosis

Keywords

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

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.

Detailed description

Routine use of thromboprophylaxis may be over treatment and definitely increases healthcare costs. While prophylaxis may reduce the number of thrombi formed the exact number and clinical significance of these is unknown. This study seeks to answer the question of whether or not DVT prophylaxis with low-molecular-weight heparin (LMWH) following ORIF of ankle fractures is warranted.

Interventions

DRUGLow-Molecular-Weight Heparin

Isolated Ankle Fracture Single planned operation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.	first post-operative office visit (usually 10-14 days)

Secondary

Measure	Time frame
We may find that there is in fact significant benefit to giving prophylaxis to this subset of patients in the form of decreased rates of throb\mbus formation and the complications related to thrombi. The risk/benefit ratio should be favorable.	first post-operative office visit (10-14 days)

Countries

United States

Contacts

Primary ContactStan Ragon, M.D.

stanragon@hotmail.com423-778-9202

Backup ContactElaine Pugh

elaine.pugh@erlanger.org423-778-5663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026