Trial Outcomes & Findings for Hemorrhage Risk Prescribed Arixtra (NCT NCT01064362)
NCT ID: NCT01064362
Last Updated: 2015-05-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
13442 participants
Primary outcome timeframe
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
Results posted on
2015-05-12
Participant Flow
Participant milestones
| Measure |
Fondaparinux
All dosages of fondaparinux
|
Low Molecular Weight Heparins (LMWHs)
All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
|
|---|---|---|
|
Overall Study
STARTED
|
1559
|
11883
|
|
Overall Study
COMPLETED
|
1559
|
11883
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hemorrhage Risk Prescribed Arixtra
Baseline characteristics by cohort
| Measure |
Fondaparinux
n=1559 Participants
All dosages of fondaparinux
|
Low Molecular Weight Heparins (LMWHs)
n=11883 Participants
All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
|
Total
n=13442 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-64 years
|
478 Participants
n=5 Participants
|
2962 Participants
n=7 Participants
|
3440 Participants
n=5 Participants
|
|
Age, Customized
65-74 years
|
568 Participants
n=5 Participants
|
3433 Participants
n=7 Participants
|
4001 Participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
513 Participants
n=5 Participants
|
5488 Participants
n=7 Participants
|
6001 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1098 Participants
n=5 Participants
|
8280 Participants
n=7 Participants
|
9378 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
461 Participants
n=5 Participants
|
3603 Participants
n=7 Participants
|
4064 Participants
n=5 Participants
|
|
Number of participants with the indicated duration of their in-hospital stay
0-7 days
|
994 participants
n=5 Participants
|
4826 participants
n=7 Participants
|
5820 participants
n=5 Participants
|
|
Number of participants with the indicated duration of their in-hospital stay
8-10 days
|
428 participants
n=5 Participants
|
2965 participants
n=7 Participants
|
3393 participants
n=5 Participants
|
|
Number of participants with the indicated duration of their in-hospital stay
11-14 days
|
75 participants
n=5 Participants
|
1608 participants
n=7 Participants
|
1683 participants
n=5 Participants
|
|
Number of participants with the indicated duration of their in-hospital stay
>=15 days
|
62 participants
n=5 Participants
|
2484 participants
n=7 Participants
|
2546 participants
n=5 Participants
|
|
Number of participants hospitalized because of hip surgery and knee surgery
Knee surgery
|
414 participants
n=5 Participants
|
3073 participants
n=7 Participants
|
3487 participants
n=5 Participants
|
|
Number of participants hospitalized because of hip surgery and knee surgery
Hip surgery
|
1145 participants
n=5 Participants
|
8810 participants
n=7 Participants
|
9955 participants
n=5 Participants
|
|
Number of participants with the indicated duration of follow-up
1-14 days
|
790 participants
n=5 Participants
|
4331 participants
n=7 Participants
|
5121 participants
n=5 Participants
|
|
Number of participants with the indicated duration of follow-up
15-28 days
|
477 participants
n=5 Participants
|
1196 participants
n=7 Participants
|
1673 participants
n=5 Participants
|
|
Number of participants with the indicated duration of follow-up
29-42 days
|
127 participants
n=5 Participants
|
2232 participants
n=7 Participants
|
2359 participants
n=5 Participants
|
|
Number of participants with the indicated duration of follow-up
>=43 days
|
165 participants
n=5 Participants
|
4124 participants
n=7 Participants
|
4289 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
PAU: Heparin
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
PAU: LMWHs
|
3 participants
n=5 Participants
|
42 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
PAU: Vitamin K Antagonist (VKA)
|
30 participants
n=5 Participants
|
351 participants
n=7 Participants
|
381 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
PAU: Fondaparinux
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
PAU: Multiple agents
|
0 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Use of platelet inhibitors
|
293 participants
n=5 Participants
|
2610 participants
n=7 Participants
|
2903 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Use of ns-NSAIDs
|
395 participants
n=5 Participants
|
2717 participants
n=7 Participants
|
3112 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Hospitalization for hypercoagulable state
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Hospitalization for cancer
|
7 participants
n=5 Participants
|
100 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Hospitalization for thrombocytopenia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Hypertension
|
764 participants
n=5 Participants
|
5645 participants
n=7 Participants
|
6409 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Cardiovascular disease
|
378 participants
n=5 Participants
|
2923 participants
n=7 Participants
|
3301 participants
n=5 Participants
|
|
Number of participants with the indicated major risk factors or other key characteristics
Hospitalization for cerebrovascular disease
|
1 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 firstPopulation: 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.
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.
Outcome measures
| Measure |
Fondaparinux
n=1559 Participants
All dosages of fondaparinux
|
Low Molecular Weight Heparins (LMWHs)
n=11883 Participants
All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
|
|---|---|---|
|
Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Bleeding or hematoma as complication of a surgery
|
7 participants
|
10 participants
|
|
Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Epistaxis
|
0 participants
|
3 participants
|
|
Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Gastrointestinal bleeds
|
0 participants
|
9 participants
|
|
Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Hemarthrosis
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Intracranial bleeds
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Urinary tract bleeding
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Fondaparinux
n=1559 Participants
All dosages of fondaparinux
|
Low Molecular Weight Heparins (LMWHs)
n=11883 Participants
All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
|
|---|---|---|
|
Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Bleeding or hematoma as complication of a surgery
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Epistaxis
|
0 participants
|
1 participants
|
Adverse Events
Fondaparinux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Molecular Weight Heparins (LMWHs)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER