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Hemorrhage Risk Prescribed Arixtra

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ClinicalTrials.gov Identifier: NCT01064362
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : February 11, 2011
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Thrombosis, Venous
Interventions Drug: Fondaparinux sodium
Drug: Low molecular weight heparin (LMWH)
Enrollment 13442
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fondaparinux Low Molecular Weight Heparins (LMWHs)
Hide Arm/Group Description All dosages of fondaparinux All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
Period Title: Overall Study
Started 1559 11883
Completed 1559 11883
Not Completed 0 0
Arm/Group Title Fondaparinux Low Molecular Weight Heparins (LMWHs) Total
Hide Arm/Group Description All dosages of fondaparinux All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin Total of all reporting groups
Overall Number of Baseline Participants 1559 11883 13442
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1559 participants 11883 participants 13442 participants
18-64 years 478 2962 3440
65-74 years 568 3433 4001
>=75 years 513 5488 6001
[1]
Measure Description: Number of participants falling into the indicated age ranges
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1559 participants 11883 participants 13442 participants
Female
1098
  70.4%
8280
  69.7%
9378
  69.8%
Male
461
  29.6%
3603
  30.3%
4064
  30.2%
Number of participants with the indicated duration of their in-hospital stay  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1559 participants 11883 participants 13442 participants
0-7 days 994 4826 5820
8-10 days 428 2965 3393
11-14 days 75 1608 1683
>=15 days 62 2484 2546
Number of participants hospitalized because of hip surgery and knee surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1559 participants 11883 participants 13442 participants
Knee surgery 414 3073 3487
Hip surgery 1145 8810 9955
Number of participants with the indicated duration of follow-up   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1559 participants 11883 participants 13442 participants
1-14 days 790 4331 5121
15-28 days 477 1196 1673
29-42 days 127 2232 2359
>=43 days 165 4124 4289
[1]
Measure Description: Follow-up includes time in the hospital.
Number of participants with the indicated major risk factors or other key characteristics   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1559 participants 11883 participants 13442 participants
PAU: Heparin 0 1 1
PAU: LMWHs 3 42 45
PAU: Vitamin K Antagonist (VKA) 30 351 381
PAU: Fondaparinux 2 0 2
PAU: Multiple agents 0 11 11
Use of platelet inhibitors 293 2610 2903
Use of ns-NSAIDs 395 2717 3112
Hospitalization for hypercoagulable state 0 0 0
Hospitalization for cancer 7 100 107
Hospitalization for thrombocytopenia 1 0 1
Hypertension 764 5645 6409
Cardiovascular disease 378 2923 3301
Hospitalization for cerebrovascular disease 1 30 31
[1]
Measure Description: Non-specific non-steroidal anti-inflammatory drugs, ns-NSAIDs; PAU, prior antithrombotic use.
1.Primary Outcome
Title Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Hide Description Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.
Time Frame Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first
Hide Outcome Measure Data
Hide Analysis Population Description
From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.
Arm/Group Title Fondaparinux Low Molecular Weight Heparins (LMWHs)
Hide Arm/Group Description:
All dosages of fondaparinux
All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
Overall Number of Participants Analyzed 1559 11883
Measure Type: Number
Unit of Measure: participants
Bleeding or hematoma as complication of a surgery 7 10
Epistaxis 0 3
Gastrointestinal bleeds 0 9
Hemarthrosis 0 2
Intracranial bleeds 0 1
Urinary tract bleeding 1 1
2.Secondary Outcome
Title Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Hide Description Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.
Time Frame Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.
Hide Outcome Measure Data
Hide Analysis Population Description
From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.
Arm/Group Title Fondaparinux Low Molecular Weight Heparins (LMWHs)
Hide Arm/Group Description:
All dosages of fondaparinux
All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
Overall Number of Participants Analyzed 1559 11883
Measure Type: Number
Unit of Measure: participants
Bleeding or hematoma as complication of a surgery 1 0
Epistaxis 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description This is a retrospective study of pre-existing data; thus, no assessments for Serious or Non-serious Adverse Events were performed.
 
Arm/Group Title Fondaparinux Low Molecular Weight Heparins (LMWHs)
Hide Arm/Group Description All dosages of fondaparinux All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
All-Cause Mortality
Fondaparinux Low Molecular Weight Heparins (LMWHs)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fondaparinux Low Molecular Weight Heparins (LMWHs)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fondaparinux Low Molecular Weight Heparins (LMWHs)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Differences among hospitals in the registration of events (not all events were captured), the presence of policlinical pharmacy, and different drug usage patterns in each hospital did not enable a valid comparison of the risk of haemorrhage.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01064362     History of Changes
Other Study ID Numbers: 113962
EPI40612 ( Other Identifier: GSK )
WEUSRTP4388 ( Other Identifier: GSK )
First Submitted: February 4, 2010
First Posted: February 8, 2010
Results First Submitted: January 25, 2011
Results First Posted: February 11, 2011
Last Update Posted: May 12, 2015