Trial · NCT01064362
Hemorrhage Risk Prescribed Arixtra
NCT01064362, Completed, GlaxoSmithKline; results first posted 2011-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hemorrhage Risk Prescribed Arixtra. Trials, record NCT01064362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01064362
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hemorrhage Risk Prescribed Arixtra
- NCT number
- NCT01064362
- Status
- Completed
- Enrollment
- 13,442 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Thrombosis, Venous
- Interventions
- Fondaparinux sodium, Low molecular weight heparin (LMWH)
- First posted
- 2010-02-08
- Last updated
- 2015-05-12
- Results first posted
- 2011-02-11
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | 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 | 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. |
| Secondary | Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | 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. | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | 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 | 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. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | 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. | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Fondaparinux | Bleeding or hematoma as complication of a surgery | 7 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Low Molecular Weight Heparins (LMWHs) | Bleeding or hematoma as complication of a surgery | 10 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Fondaparinux | Epistaxis | 0 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Low Molecular Weight Heparins (LMWHs) | Epistaxis | 3 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Fondaparinux | Gastrointestinal bleeds | 0 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Low Molecular Weight Heparins (LMWHs) | Gastrointestinal bleeds | 9 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Fondaparinux | Hemarthrosis | 0 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Low Molecular Weight Heparins (LMWHs) | Hemarthrosis | 2 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Fondaparinux | Intracranial bleeds | 0 | participants | |
| Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) | Low Molecular Weight Heparins (LMWHs) | Intracranial bleeds | 1 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fondaparinux | 1,559 | |
| Overall Study | STARTED | Low Molecular Weight Heparins (LMWHs) | 11,883 | |
| Overall Study | COMPLETED | Fondaparinux | 1,559 | |
| Overall Study | COMPLETED | Low Molecular Weight Heparins (LMWHs) | 11,883 | |
| Overall Study | NOT COMPLETED | Fondaparinux | 0 | |
| Overall Study | NOT COMPLETED | Low Molecular Weight Heparins (LMWHs) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fondaparinux | ||
| Total, all-cause mortality | Low Molecular Weight Heparins (LMWHs) | ||
| Total, other adverse events | Fondaparinux | 0 | 0 |
| Total, other adverse events | Low Molecular Weight Heparins (LMWHs) | 0 | 0 |
| Total, serious adverse events | Fondaparinux | 0 | 0 |
| Total, serious adverse events | Low Molecular Weight Heparins (LMWHs) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01064362
GET https://conductscience.org/api/trials/v1/NCT01064362/registered