Trial · NCT00843492
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
NCT00843492, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery. Trials, record NCT00843492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00843492
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
- NCT number
- NCT00843492
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,351 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Thrombosis, Venous
- Interventions
- Fondaparinux sodium, Nadroparin
- First posted
- 2009-02-13
- Last updated
- 2016-03-16
- Results first posted
- 2012-07-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization | Day 1 to complete mobilization plus 2 days (average of 35.9 study days) | VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC). |
| Secondary | Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Day 1 to complete mobilization plus 2 days (average of 35.7 study days) | All components of the primary endpoint were considered separately: any VTE; symptomatic (providing no evidence of disease existence) DVT (the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography; symptomatic(providing evidence of disease existence) DVT; symptomatic PE (blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung of one of its branches); and death. |
| Secondary | Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact | Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days) | The number of participants with VTE (defined as asymptomatic deep vein thrombosis \[DVT: the formation of a blood clot in a deep vein\] detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism \[PE\]) and death was assessed. An embolism is a clot in the blood that forms and blocks a blood vessel. A PE is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. |
| Secondary | Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | Major bleeding is defined as bleeding that results in a fatality, symptomatic bleeding in a critical area or organ, bleeding causing a fall in hemoglobin level of 20 grams/liter (1.24 millimoles/liter) or more compared with the pre-randomization hemoglobin level, or bleeding that leads to a transfusion of two or more units of whole blood or red blood cells. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. |
| Secondary | Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | Clinically relevant non-major bleeding that does not qualify as major is defined as bleeding leading to treatment discontinuation, and/or epistaxis (bleeding through the nose) that lasts for more than 5 minutes or necessitates intervention (e.g., packing), spontaneous macroscopic haematuria (blood in urine), gastrointestinal haemorrhage, haemoptysis (coughing up blood), or subcutaneous haematoma (localized collection of blood) \> 100 centimeters squared. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. |
| Secondary | Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. |
| Secondary | Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | All episodes of bleeding, except minor bruising, skin hematomas not greater than 5 centimeters in diameter, self-limited epistaxis (bleeding through the nose), and self-limited gingival (gum) bleeding, were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. |
Source ClinicalTrials.gov
Outcomes7
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 Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization | Day 1 to complete mobilization plus 2 days (average of 35.9 study days) | Intent-to-Treat (ITT) Population: all randomized participants with a VTE status or experiencing death. Participants without evaluation of the primary endpoint in the timeframe requested by the protocol were considered as missing data and therefore not included in the primary efficacy analysis. | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Day 1 to complete mobilization plus 2 days (average of 35.7 study days) | ITT Population. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact | Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | As-Treated Population: all participants who received at least one dose of study treatment | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | As-Treated Population | participants | NUMBER |
| SECONDARY | Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | As-Treated Population | participants | NUMBER |
| SECONDARY | Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact | Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) | As-Treated Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
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 Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization | Nadroparin | 48 | participants | ||
| Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization | Fondaparinux | 15 | participants | ||
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Nadroparin | Any VTE, n=586, 583 | 48 | participants | |
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Fondaparinux | Any VTE, n=586, 583 | 14 | participants | |
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Nadroparin | Any asymptomatic DVT, n=585, 582 | 42 | participants | |
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Fondaparinux | Any asymptomatic DVT, n=585, 582 | 11 | participants | |
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Nadroparin | Any symptomatic DVT, n=622, 621 | 7 | participants | |
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Fondaparinux | Any symptomatic DVT, n=622, 621 | 2 | participants | |
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Nadroparin | Any symptomatic PE, n=622, 621 | 0 | participants | |
| Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death | Fondaparinux | Any symptomatic PE, n=622, 621 | 2 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nadroparin | 622 | |
| Overall Study | STARTED | Fondaparinux | 621 | |
| Overall Study | COMPLETED | Nadroparin | 614 | |
| Overall Study | COMPLETED | Fondaparinux | 607 | |
| Overall Study | NOT COMPLETED | Nadroparin | 8 | |
| Overall Study | NOT COMPLETED | Fondaparinux | 14 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Nadroparin | 33 | 670 | |
| other | Headache | Nervous system disorders | Fondaparinux | 24 | 674 | |
| other | Injection site haematoma | General disorders | Nadroparin | 31 | 670 | |
| other | Injection site haematoma | General disorders | Fondaparinux | 10 | 674 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Nadroparin | 18 | 670 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Fondaparinux | 21 | 674 | |
| other | Nausea | Gastrointestinal disorders | Nadroparin | 10 | 670 | |
| other | Nausea | Gastrointestinal disorders | Fondaparinux | 12 | 674 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Nadroparin | 8 | 670 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fondaparinux | 14 | 674 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nadroparin | ||
| Total, all-cause mortality | Fondaparinux | ||
| Total, other adverse events | Nadroparin | 95 | 670 |
| Total, other adverse events | Fondaparinux | 93 | 674 |
| Total, serious adverse events | Nadroparin | 9 | 670 |
| Total, serious adverse events | Fondaparinux | 6 | 674 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nadroparin vs Fondaparinux: Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact | Trial comparisons |
| Nadroparin vs Fondaparinux: Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization | Trial comparisons |
| Nadroparin vs Fondaparinux: serious adverse events | Trial comparisons |
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/NCT00843492
GET https://conductscience.org/api/trials/v1/NCT00843492/results?page=2