Phase 3 Completed N=48 Prevention

Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

Source: ClinicalTrials.gov NCT00320424 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Oct 2017

Primary outcomePrimary: Rate of Major Bleeding During Treatment Period — 21.6 % of normalized events per participant

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

This study is requested by PMDA to confirm the efficacy and the safety for HFS.

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Major Bleeding During Treatment Period	21.6	—
SECONDARY Rate of PE During Treatment Period	—	—
SECONDARY Rate of DVT During Treatment Period	21.6	—
SECONDARY Rate of Proximal DVT During Treatment Period	2.6	—
SECONDARY Rate of Distal Only DVT During Treatment Period	21.6	—
SECONDARY Number of Participants With Major Bleeding During Treatment Period	—	—
SECONDARY Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)	0; 0	—
SECONDARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death	37; 2; 0	—
SECONDARY Number of Transfused Participants	1	—
SECONDARY Summary of Units Transfused	280	—
SECONDARY Rate of Symptomatic DVT	—	—

Eligibility Criteria

Inclusion Criteria

Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).

Exclusion Criteria

Active, clinically significant bleeding (excluding drainage).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00320424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.