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Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux. (PROPICE)

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ClinicalTrials.gov Identifier: NCT00555438
Recruitment Status : Completed
First Posted : November 8, 2007
Results First Posted : November 17, 2010
Last Update Posted : August 17, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Major Orthopaedic Surgery and Renal Impairment
Intervention Drug: fondaparinux 1.5 mg/day
Enrollment 451
Recruitment Details patients have been included between june 2007 and june 2008 in public and private French hospitals
Pre-assignment Details Nine patients received no study drug due to immediate postoperative death (n=1), consent withdrawal (n=2), use of another thromboprophylactic agent (n=2), surgery change or cancellation (n=2), and CrCl >50 mL/min just before surgery (n=2)
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Period Title: 10 Days Post-operative
Started 442
Completed 438 [1]
Not Completed 4
Reason Not Completed
Death             4
[1]
438 patients attended the day 10 visit (four patients died during hospitalization)
Period Title: Between 10 Days and 30 Days Postoperativ
Started 438
Completed 433
Not Completed 5
Reason Not Completed
Death             5
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Overall Number of Baseline Participants 442
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 442 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
   1.1%
>=65 years
437
  98.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 442 participants
81.4  (6.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 442 participants
Female
353
  79.9%
Male
89
  20.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 442 participants
442
1.Primary Outcome
Title Number of Patients With Major Bleedings Between Day 1 and Day 10.
Hide Description evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L.
Time Frame 10 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description:
patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Overall Number of Participants Analyzed 442
Measure Type: Number
Unit of Measure: participants
20
2.Secondary Outcome
Title Number of Patients With Major Bleedings at 1 Month ± 5 Days.
Hide Description evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days.
Time Frame 45 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description:
patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Overall Number of Participants Analyzed 442
Measure Type: Number
Unit of Measure: participants
23
3.Secondary Outcome
Title Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10
Hide Description Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description:
patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Overall Number of Participants Analyzed 442
Measure Type: Number
Unit of Measure: participants
2
4.Secondary Outcome
Title Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days
Hide Description Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days.
Time Frame at 1 month ± 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description:
patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Overall Number of Participants Analyzed 442
Measure Type: Number
Unit of Measure: participants
3
5.Secondary Outcome
Title Death at 1 Month ± 5 Days
Hide Description Evaluate the total number of death at 1 month ± 5 days
Time Frame 1 month ± 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description:
patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Overall Number of Participants Analyzed 442
Measure Type: Number
Unit of Measure: participants
10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fondaparinux 1.5 mg/l
Hide Arm/Group Description patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
All-Cause Mortality
Fondaparinux 1.5 mg/l
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Fondaparinux 1.5 mg/l
Affected / at Risk (%) # Events
Total   32/442 (7.24%)    
Cardiac disorders   
acute coronary syndrome   2/442 (0.45%)  38
acute myocardial infarction   1/442 (0.23%)  38
Atrial fibrillation paroxysmal   1/442 (0.23%)  38
cardio-respiratory failure   1/442 (0.23%)  38
Gastrointestinal disorders   
Hiatus hernia   1/442 (0.23%)  38
Infarction mesenteric   1/442 (0.23%)  38
Vomiting   1/442 (0.23%)  38
gastrointestinal disorder NOS   1/442 (0.23%)  38
Gastroduodenal hemorrhage   1/442 (0.23%)  38
distal intestinal obstruction syndrome   1/442 (0.23%)  38
proctorrhagia   1/442 (0.23%)  38
Small intestine obstruction   1/442 (0.23%)  38
Gastrointestinal obstruction NOS   1/442 (0.23%)  38
General disorders   
malaise   1/442 (0.23%)  38
general physical health deterioration   2/442 (0.45%)  38
Infections and infestations   
Diarrhea, Clostridium difficile   1/442 (0.23%)  38
septic shock   2/442 (0.45%)  38
Bronchopulmonary infection   1/442 (0.23%)  38
incision site infection   3/442 (0.68%)  38
Injury, poisoning and procedural complications   
prosthesis fracture   1/442 (0.23%)  38
incision site hematoma   3/442 (0.68%)  38
anemia postoperative   1/442 (0.23%)  38
incision site inflammation   1/442 (0.23%)  38
femoral greater trochanter fracture   1/442 (0.23%)  38
Fracture of neck of femur   1/442 (0.23%)  38
deep vein thrombosis postoperative   1/442 (0.23%)  38
Nervous system disorders   
transient cerebral ischemia   1/442 (0.23%)  38
ischemic strocke   1/442 (0.23%)  38
Reproductive system and breast disorders   
Respiratort insufficiency   1/442 (0.23%)  38
Respiratory, thoracic and mediastinal disorders   
acute pulmonary edaema   2/442 (0.45%)  38
Pneumothorax NOS   1/442 (0.23%)  38
Vascular disorders   
mesenteric ischemia   1/442 (0.23%)  38
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fondaparinux 1.5 mg/l
Affected / at Risk (%) # Events
Total   0/442 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pr patrick MISMETTI
Organization: CHU SAINT-ETIENNE
Phone: 33(1)477127788
EMail: patrick.mismetti@chu-st-etienne.fr
Layout table for additonal information
Responsible Party: Pr Patrick MISMETTI, Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00555438    
Other Study ID Numbers: 0701017
2007-001048-32 ( EudraCT Number )
First Submitted: November 7, 2007
First Posted: November 8, 2007
Results First Submitted: September 15, 2010
Results First Posted: November 17, 2010
Last Update Posted: August 17, 2011