ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement

NCT00298285 | Completed Phase 4

• 1 other identifier: ABRIDGE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to determine the rate of major bleeding and blood clots when using enoxaparin as a bridge to oral blood thinning medication in patients who have undergone mechanical valve replacement.

Conditions

Mechanical Valve Replacement; Warfarin Therapy

Keywords

mechanical valve replacement; warfarin

Outcome Measures

Primary Outcomes (2)

• arterial thromboembolism

• major bleeding

Interventions

enoxaparin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting all the following will be considered for enrollment.
• Male or non-pregnant female (negative pregnancy test is required for women of child bearing potential) ≥ 18 of age who are able to provide informed consent and able to self-administer enoxaparin.
• Body weight ≥ 45kg and ≤ 150kg.
• Patients who are post prosthetic mechanical valve surgery and will need oral anticoagulation after discharge from the hospital.
• One who has undergone valve replacement with mechanical prosthesis in the mitral position.
• One who has undergone valve replacement with mechanical prosthesis in the aortic position.
• One who has undergone valve replacement with mechanical prosthesis in the tricuspid position.

You may not qualify if:

• Patients with any of the following will not be eligible for enrollment in the study:
• Contraindication or sensitivity to unfractionated heparin/ low molecular weight heparin: history of heparin associated thrombocytopenia, heparin induced thrombocytopenia, or heparin induced thrombotic thrombocytopenia syndrome;
• History of, or current, cardiogenic shock;
• Active endocarditis (requiring \> 4 weeks of antibiotics);
• Active bleeding or bleeding diathesis;
• History of gastrointestinal bleeding and /or endoscopically verified ulcer disease within the last three months;
• Known proliferative diabetic retinopathy or history of intraocular bleeding;
• Ischemic stroke in the previous three months or any hemorrhagic stroke, known brain tumor, intracranial aneurysm or intracranial AV malformation;
• Renal insufficiency (cr clearance \< 30 cc/min), cr clearance calculation:
• Women = 0.85 x (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), Men = (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), or patient with a renal transplant;
• Anemia (Hgb \< 8 gm/dl);
• Thrombocytopenia (platelet count \< 100 x 109/L);
• Liver disease demonstrated by ALT \> 144u/L
• Uncontrolled hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure \>100mmHg);
• Life expectancy less than 6 months;

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Allan Klein, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 2, 2006
• Study Completion: October 1, 2006
• Last Updated: November 9, 2007

Record last verified: 2006-01

Locations

US (1)