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Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)

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ClinicalTrials.gov Identifier: NCT00786474
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Arterial Thromboembolic Events
Atrial Fibrillation
Interventions Drug: Placebo
Drug: Dalteparin
Enrollment 1884
Recruitment Details 6585 subjects were screened. 4701 were excluded, 1884 subjects enrolled and underwent randomization.
Pre-assignment Details  
Arm/Group Title Placebo Dalteparin
Hide Arm/Group Description Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Period Title: Overall Study
Started 950 934
Completed 913 891
Not Completed 37 43
Reason Not Completed
Death             5             4
Withdrawal by Subject             23             31
Lost to Follow-up             3             3
Physician Decision             2             1
Not Specified             4             4
Arm/Group Title Placebo Dalteparin Total
Hide Arm/Group Description Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day Total of all reporting groups
Overall Number of Baseline Participants 950 934 1884
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 950 participants 934 participants 1884 participants
71.8  (8.74) 71.6  (8.88) 71.7  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 950 participants 934 participants 1884 participants
Female
254
  26.7%
248
  26.6%
502
  26.6%
Male
696
  73.3%
686
  73.4%
1382
  73.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 950 participants 934 participants 1884 participants
White 860 849 1709
Nonwhite 88 82 170
Unknown 2 3 5
1.Primary Outcome
Title Number of Arterial Thromboembolic Events
Hide Description The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated
Time Frame from subject signing of the consent until completed the study (Day -30 to Day +37)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.
Arm/Group Title Placebo Dalteparin
Hide Arm/Group Description:
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Overall Number of Participants Analyzed 918 895
Measure Type: Number
Unit of Measure: Arterial thromboembolic events
Stroke 2 3
Transient Ischemic Attack 2 0
Systemic embolism 0 0
2.Primary Outcome
Title Major Bleeding
Hide Description Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death
Time Frame from subject signing of the consent until completed the study (Day -30 to Day +37)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.
Arm/Group Title Placebo Dalteparin
Hide Arm/Group Description:
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Overall Number of Participants Analyzed 918 895
Measure Type: Number
Unit of Measure: participants
12 29
3.Secondary Outcome
Title Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism
Hide Description [Not Specified]
Time Frame from subject signing of the consent until completed the study (Day -30 to Day +37)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.
Arm/Group Title Placebo Dalteparin
Hide Arm/Group Description:
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Overall Number of Participants Analyzed 918 895
Measure Type: Number
Unit of Measure: participants
Death 5 4
Myocardial infarction 7 14
Deep-vein thrombosis 0 1
pulmonary embolism 0 1
4.Secondary Outcome
Title Number of Participants With Minor Bleeding
Hide Description Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding
Time Frame from subject signing of the consent until completed the study (Day -30 to Day +37)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data
Arm/Group Title Placebo Dalteparin
Hide Arm/Group Description:
Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Overall Number of Participants Analyzed 918 895
Measure Type: Number
Unit of Measure: participants
110 187
Time Frame from subject signing of the consent until completed the study from Day -30 to Day +37
Adverse Event Reporting Description Study only collected and reported serious adverse events
 
Arm/Group Title Placebo Dalteparin
Hide Arm/Group Description Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
All-Cause Mortality
Placebo Dalteparin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dalteparin
Affected / at Risk (%) Affected / at Risk (%)
Total   66/950 (6.95%)   133/934 (14.24%) 
Blood and lymphatic system disorders     
Coagulopathy   0/950 (0.00%)  1/934 (0.11%) 
Hypocoagulable State   0/950 (0.00%)  1/934 (0.11%) 
Cardiac disorders     
Acute Coronary Syndrome   0/950 (0.00%)  1/934 (0.11%) 
Acute Myocardial Infarction   0/950 (0.00%)  3/934 (0.32%) 
Angina Pectoris   1/950 (0.11%)  1/934 (0.11%) 
Atrial Fibrillation   2/950 (0.21%)  3/934 (0.32%) 
Atrial Flutter   1/950 (0.11%)  1/934 (0.11%) 
Atrioventricular Block Second Degree   0/950 (0.00%)  1/934 (0.11%) 
Bradycardia   1/950 (0.11%)  0/934 (0.00%) 
Cardiac Arrest   0/950 (0.00%)  1/934 (0.11%) 
Cardiac Failure   1/950 (0.11%)  1/934 (0.11%) 
Cardiac Failure Congestive   4/950 (0.42%)  5/934 (0.54%) 
Coronary Artery Disease   0/950 (0.00%)  1/934 (0.11%) 
Ischaemic Cardiomyopathy   0/950 (0.00%)  1/934 (0.11%) 
Myocardial Infarction   2/950 (0.21%)  2/934 (0.21%) 
Pericardial Effusion   0/950 (0.00%)  1/934 (0.11%) 
Pericarditis   1/950 (0.11%)  0/934 (0.00%) 
Sick Sinus Syndrome   0/950 (0.00%)  1/934 (0.11%) 
Ventricular Fibrillation   0/950 (0.00%)  1/934 (0.11%) 
Ventricular Tachycardia   0/950 (0.00%)  2/934 (0.21%) 
Endocrine disorders     
Adrenal Haemorrhage   0/950 (0.00%)  1/934 (0.11%) 
Gastrointestinal disorders     
Ascites   1/950 (0.11%)  0/934 (0.00%) 
Duodenal Ulcer Perforation   0/950 (0.00%)  1/934 (0.11%) 
Dysphagia   1/950 (0.11%)  0/934 (0.00%) 
Gastric Perforation   0/950 (0.00%)  1/934 (0.11%) 
Gastrointestinal Haemorrhage   0/950 (0.00%)  4/934 (0.43%) 
Haematochezia   0/950 (0.00%)  1/934 (0.11%) 
Ileus   1/950 (0.11%)  0/934 (0.00%) 
Inguinal Hernia   1/950 (0.11%)  0/934 (0.00%) 
Intestinal Obstruction   0/950 (0.00%)  1/934 (0.11%) 
Intestinal Perforation   0/950 (0.00%)  1/934 (0.11%) 
Lower Gastrointestinal Haemorrhage   1/950 (0.11%)  1/934 (0.11%) 
Pancreatic Haemorrhage   0/950 (0.00%)  1/934 (0.11%) 
Rectal Haemorrhage   1/950 (0.11%)  6/934 (0.64%) 
Retroperitoneal Haemorrhage   0/950 (0.00%)  1/934 (0.11%) 
Vomiting   0/950 (0.00%)  1/934 (0.11%) 
General disorders     
Cardiac Death   1/950 (0.11%)  0/934 (0.00%) 
Chest Pain   0/950 (0.00%)  1/934 (0.11%) 
Influenza Like Illness   0/950 (0.00%)  1/934 (0.11%) 
Multi-Organ Failure   1/950 (0.11%)  0/934 (0.00%) 
Non-Cardiac Chest Pain   1/950 (0.11%)  0/934 (0.00%) 
Oedema Peripheral   0/950 (0.00%)  1/934 (0.11%) 
Pyrexia   0/950 (0.00%)  1/934 (0.11%) 
Cholangitis   0/950 (0.00%)  1/934 (0.11%) 
Hepatobiliary disorders     
Cholecystitis   1/950 (0.11%)  0/934 (0.00%) 
Cholecystitis Acute   0/950 (0.00%)  1/934 (0.11%) 
Gallbladder Fistula   0/950 (0.00%)  1/934 (0.11%) 
Hepatic Cirrhosis   1/950 (0.11%)  0/934 (0.00%) 
Arthritis Bacterial   0/950 (0.00%)  1/934 (0.11%) 
Infections and infestations     
Arthritis Infective   1/950 (0.11%)  0/934 (0.00%) 
Bronchitis   0/950 (0.00%)  1/934 (0.11%) 
Cellulitis   0/950 (0.00%)  2/934 (0.21%) 
Gastroenteritis   1/950 (0.11%)  0/934 (0.00%) 
Infection   0/950 (0.00%)  1/934 (0.11%) 
Influenza   0/950 (0.00%)  1/934 (0.11%) 
Lower Respiratory Tract Infection   0/950 (0.00%)  1/934 (0.11%) 
Osteomyelitis   0/950 (0.00%)  1/934 (0.11%) 
Perirectal Abscess   0/950 (0.00%)  1/934 (0.11%) 
Peritonsillar Abscess   1/950 (0.11%)  0/934 (0.00%) 
Pneumonia   1/950 (0.11%)  5/934 (0.54%) 
Postoperative Wound Infection   1/950 (0.11%)  0/934 (0.00%) 
Sepsis   0/950 (0.00%)  2/934 (0.21%) 
Urinary Tract Infection   1/950 (0.11%)  2/934 (0.21%) 
Urosepsis   0/950 (0.00%)  1/934 (0.11%) 
Injury, poisoning and procedural complications     
Fall   1/950 (0.11%)  0/934 (0.00%) 
Incision Site Haemorrhage   0/950 (0.00%)  1/934 (0.11%) 
Joint Dislocation   1/950 (0.11%)  0/934 (0.00%) 
Laceration   0/950 (0.00%)  1/934 (0.11%) 
Limb Injury   0/950 (0.00%)  1/934 (0.11%) 
Post Procedural Haematoma   1/950 (0.11%)  5/934 (0.54%) 
Post Procedural Haemorrhage   3/950 (0.32%)  4/934 (0.43%) 
Procedural Haemorrhage   0/950 (0.00%)  1/934 (0.11%) 
Road Traffic Accident   1/950 (0.11%)  1/934 (0.11%) 
Spinal Compression Fracture   1/950 (0.11%)  0/934 (0.00%) 
Splenic Rupture   0/950 (0.00%)  1/934 (0.11%) 
Traumatic Fracture   1/950 (0.11%)  0/934 (0.00%) 
Traumatic Haematoma   1/950 (0.11%)  0/934 (0.00%) 
Urinary Retention Postoperative   1/950 (0.11%)  0/934 (0.00%) 
Vaginal Laceration   1/950 (0.11%)  0/934 (0.00%) 
Investigations     
Blood Culture Positive   0/950 (0.00%)  1/934 (0.11%) 
Electrocardiogram Qt Prolonged   0/950 (0.00%)  1/934 (0.11%) 
Haemoglobin Decreased   2/950 (0.21%)  1/934 (0.11%) 
Metabolism and nutrition disorders     
Dehydration   1/950 (0.11%)  1/934 (0.11%) 
Gout   0/950 (0.00%)  1/934 (0.11%) 
Hyperglycaemia   0/950 (0.00%)  1/934 (0.11%) 
Hyperkalaemia   0/950 (0.00%)  1/934 (0.11%) 
Hyperosmolar State   0/950 (0.00%)  1/934 (0.11%) 
Hyponatraemia   1/950 (0.11%)  0/934 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Chest Pain   1/950 (0.11%)  0/934 (0.00%) 
Soft Tissue Haemorrhage   0/950 (0.00%)  1/934 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma Of Colon   0/950 (0.00%)  1/934 (0.11%) 
Bladder Neoplasm   1/950 (0.11%)  0/934 (0.00%) 
Endometrial Adenocarcinoma   0/950 (0.00%)  1/934 (0.11%) 
Hepatic Cancer   1/950 (0.11%)  0/934 (0.00%) 
Intraductal Proliferative Breast Lesion   1/950 (0.11%)  0/934 (0.00%) 
Oesophageal Carcinoma   0/950 (0.00%)  1/934 (0.11%) 
Nervous system disorders     
Cerebrovascular Accident   0/950 (0.00%)  3/934 (0.32%) 
Dizziness   0/950 (0.00%)  1/934 (0.11%) 
Embolic Stroke   1/950 (0.11%)  0/934 (0.00%) 
Ischaemic Stroke   1/950 (0.11%)  0/934 (0.00%) 
Migraine   1/950 (0.11%)  0/934 (0.00%) 
Presyncope   0/950 (0.00%)  1/934 (0.11%) 
Syncope   3/950 (0.32%)  2/934 (0.21%) 
Transient Ischaemic Attack   2/950 (0.21%)  1/934 (0.11%) 
Psychiatric disorders     
Delirium   1/950 (0.11%)  0/934 (0.00%) 
Renal and urinary disorders     
Haematuria   1/950 (0.11%)  5/934 (0.54%) 
Renal Failure   0/950 (0.00%)  1/934 (0.11%) 
Renal Failure Acute   1/950 (0.11%)  1/934 (0.11%) 
Urethral Obstruction   1/950 (0.11%)  0/934 (0.00%) 
Urinary Bladder Rupture   0/950 (0.00%)  1/934 (0.11%) 
Urinary Retention   1/950 (0.11%)  0/934 (0.00%) 
Urinary Tract Obstruction   0/950 (0.00%)  1/934 (0.11%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease   2/950 (0.21%)  3/934 (0.32%) 
Haemoptysis   0/950 (0.00%)  1/934 (0.11%) 
Pleural Effusion   0/950 (0.00%)  1/934 (0.11%) 
Pulmonary Embolism   0/950 (0.00%)  1/934 (0.11%) 
Respiratory Failure   0/950 (0.00%)  2/934 (0.21%) 
Vascular disorders     
Deep Vein Thrombosis   0/950 (0.00%)  2/934 (0.21%) 
Haematoma   1/950 (0.11%)  1/934 (0.11%) 
Haemorrhage   0/950 (0.00%)  1/934 (0.11%) 
Hypertensive Crisis   0/950 (0.00%)  1/934 (0.11%) 
Hypotension   0/950 (0.00%)  2/934 (0.21%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Dalteparin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00786474     History of Changes
Other Study ID Numbers: Pro00017344
1U01HL086755-01A1 ( U.S. NIH Grant/Contract )
1U01HL087229 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2008
First Posted: November 6, 2008
Results First Submitted: January 6, 2016
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016