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Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00786474
First received: November 5, 2008
Last updated: February 8, 2016
Last verified: January 2016
Results First Received: January 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Arterial Thromboembolic Events
Atrial Fibrillation
Interventions: Drug: Placebo
Drug: Dalteparin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
6585 subjects were screened. 4701 were excluded, 1884 subjects enrolled and underwent randomization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
Dalteparin Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day

Participant Flow:   Overall Study
    Placebo     Dalteparin  
STARTED     950     934  
COMPLETED     913     891  
NOT COMPLETED     37     43  
Death                 5                 4  
Withdrawal by Subject                 23                 31  
Lost to Follow-up                 3                 3  
Physician Decision                 2                 1  
Not Specified                 4                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
Dalteparin Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Total Total of all reporting groups

Baseline Measures
    Placebo     Dalteparin     Total  
Number of Participants  
[units: participants]
  950     934     1884  
Age  
[units: years]
Mean (Standard Deviation)
  71.8  (8.74)     71.6  (8.88)     71.7  (8.8)  
Gender  
[units: participants]
     
Female     254     248     502  
Male     696     686     1382  
Race/Ethnicity, Customized  
[units: participants]
     
White     860     849     1709  
Nonwhite     88     82     170  
Unknown     2     3     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Arterial Thromboembolic Events   [ Time Frame: from subject signing of the consent until completed the study (Day -30 to Day +37) ]

2.  Primary:   Major Bleeding   [ Time Frame: from subject signing of the consent until completed the study (Day -30 to Day +37) ]

3.  Secondary:   Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism   [ Time Frame: from subject signing of the consent until completed the study (Day -30 to Day +37) ]

4.  Secondary:   Number of Participants With Minor Bleeding   [ Time Frame: from subject signing of the consent until completed the study (Day -30 to Day +37) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Thomas Ortel, MD, PhD, Principal Investigator
Organization: Duke University Medical Center
phone: 919-684-5350 ext 3
e-mail: thomas.ortel@duke.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00786474     History of Changes
Other Study ID Numbers: Pro00017344
1U01HL086755-01A1 ( US NIH Grant/Contract Award Number )
1U01HL087229 ( US NIH Grant/Contract Award Number )
Study First Received: November 5, 2008
Results First Received: January 6, 2016
Last Updated: February 8, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board