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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

Recruitment Details	6585 subjects were screened. 4701 were excluded, 1884 subjects enrolled and underwent randomization.
Pre-assignment Details


Arm/Group Title	Placebo	Dalteparin
Arm/Group Description	Placebo: Normal saline solution, do...	Dalteparin: Low molecular weight he...
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
Other	4	4

Baseline Characteristics

Arm/Group Title		Placebo	Dalteparin	Total
Arm/Group Description		Placebo: Normal saline solution, do...	Dalteparin: Low molecular weight he...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

1.Primary Outcome


Title	Number of Arterial Thromboembolic Events
Description	The events are defined as arterial thromboembolism: stokes, transient ...
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)

Outcome Measure Data

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
Arm/Group Description:	Placebo: Normal saline solution, do...	Dalteparin: Low molecular weight he...
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
Description	Major bleeding is defined as symptomatic bleeding associated with tran...
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)

Outcome Measure Data

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
Arm/Group Description:	Placebo: Normal saline solution, do...	Dalteparin: Low molecular weight he...
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	from subject signing of the consent until completed the study (Day -30 to Day +37)

Outcome Measure Data

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
Arm/Group Description:	Placebo: Normal saline solution, do...	Dalteparin: Low molecular weight he...
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
Description	Minor bleeding is defined as symptomatic or clinically-overt bleeding ...
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)

Outcome Measure Data

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
Arm/Group Description:	Placebo: Normal saline solution, do...	Dalteparin: Low molecular weight he...
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

Adverse Events

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
Arm/Group Description	Placebo: Normal saline solution, do...	Dalteparin: Low molecular weight he...
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	--/--	--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Layout table for Results Point of Contact information

Name/Title:	Thomas Ortel, MD, PhD, Principal Investigator
Organization:	Duke University Medical Center
Phone:	919-684-5350 ext 3
EMail:	thomas.ortel@duke.edu

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

Wight JM, Columb MO. Perioperative bridging anticoagulation for atrial fibrillation-the first randomised controlled trial. Perioper Med (Lond). 2016 Jun 7;5:14. doi: 10.1186/s13741-016-0040-5. eCollection 2016.

Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.

Assaad B, Sesi VK, Figari R, Schultz L, Thummala N, Rehman M, Chandok A, Silverman A, Silver B. Antithrombotic management of stroke patients before colonoscopy. J Stroke Cerebrovasc Dis. 2013 Aug;22(6):733-6. doi: 10.1016/j.jstrokecerebrovasdis.2011.12.006. Epub 2012 Jan 12.

Layout table for additonal information

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00786474
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

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