Trial Outcomes & Findings for Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux. (NCT NCT00555438)

Last Updated: 2011-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

451 participants

Primary outcome timeframe

10 day

Results posted on

2011-08-17

Participant Flow

patients have been included between june 2007 and june 2008 in public and private French hospitals

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)

Participant milestones

Participant milestones
Measure	Fondaparinux 1.5 mg/l patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
10 Days Post-operative STARTED	442
10 Days Post-operative COMPLETED	438
10 Days Post-operative NOT COMPLETED	4
Between 10 Days and 30 Days Postoperativ STARTED	438
Between 10 Days and 30 Days Postoperativ COMPLETED	433
Between 10 Days and 30 Days Postoperativ NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Fondaparinux 1.5 mg/l patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
10 Days Post-operative Death	4
Between 10 Days and 30 Days Postoperativ Death	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fondaparinux 1.5 mg/l n=442 Participants patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	437 Participants n=5 Participants
Age Continuous	81.4 years STANDARD_DEVIATION 6.64 • n=5 Participants
Sex: Female, Male Female	353 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants
Region of Enrollment France	442 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 day

Outcome measures

Outcome measures
Measure	Fondaparinux 1.5 mg/l n=442 Participants patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Number of Patients With Major Bleedings Between Day 1 and Day 10.	20 participants

SECONDARY outcome

Timeframe: 45 day

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.

Outcome measures

Outcome measures
Measure	Fondaparinux 1.5 mg/l n=442 Participants patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Number of Patients With Major Bleedings at 1 Month ± 5 Days.	23 participants

SECONDARY outcome

Timeframe: 10 days

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.

Outcome measures

Outcome measures
Measure	Fondaparinux 1.5 mg/l n=442 Participants patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10	2 participants

SECONDARY outcome

Timeframe: at 1 month ± 5

Outcome measures

Outcome measures
Measure	Fondaparinux 1.5 mg/l n=442 Participants patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days	3 participants

SECONDARY outcome

Timeframe: 1 month ± 5 days

Evaluate the total number of death at 1 month ± 5 days

Outcome measures

Outcome measures
Measure	Fondaparinux 1.5 mg/l n=442 Participants patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Death at 1 Month ± 5 Days	10 participants

Adverse Events

Fondaparinux 1.5 mg/l

Serious events: 32 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fondaparinux 1.5 mg/l n=442 participants at risk patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Gastrointestinal disorders Hiatus hernia	0.23% 1/442 • Number of events 38
Gastrointestinal disorders Infarction mesenteric	0.23% 1/442 • Number of events 38
Gastrointestinal disorders Vomiting	0.23% 1/442 • Number of events 38
Gastrointestinal disorders gastrointestinal disorder NOS	0.23% 1/442 • Number of events 38
Gastrointestinal disorders Gastroduodenal hemorrhage	0.23% 1/442 • Number of events 38
Gastrointestinal disorders distal intestinal obstruction syndrome	0.23% 1/442 • Number of events 38
Gastrointestinal disorders proctorrhagia	0.23% 1/442 • Number of events 38
Gastrointestinal disorders Small intestine obstruction	0.23% 1/442 • Number of events 38
Gastrointestinal disorders Gastrointestinal obstruction NOS	0.23% 1/442 • Number of events 38
Infections and infestations Diarrhea, Clostridium difficile	0.23% 1/442 • Number of events 38
Infections and infestations septic shock	0.45% 2/442 • Number of events 38
Infections and infestations Bronchopulmonary infection	0.23% 1/442 • Number of events 38
Infections and infestations incision site infection	0.68% 3/442 • Number of events 38
Injury, poisoning and procedural complications prosthesis fracture	0.23% 1/442 • Number of events 38
Injury, poisoning and procedural complications incision site hematoma	0.68% 3/442 • Number of events 38
Injury, poisoning and procedural complications anemia postoperative	0.23% 1/442 • Number of events 38
Injury, poisoning and procedural complications incision site inflammation	0.23% 1/442 • Number of events 38
Injury, poisoning and procedural complications femoral greater trochanter fracture	0.23% 1/442 • Number of events 38
Injury, poisoning and procedural complications Fracture of neck of femur	0.23% 1/442 • Number of events 38
Injury, poisoning and procedural complications deep vein thrombosis postoperative	0.23% 1/442 • Number of events 38
Cardiac disorders acute coronary syndrome	0.45% 2/442 • Number of events 38
Cardiac disorders acute myocardial infarction	0.23% 1/442 • Number of events 38
Cardiac disorders Atrial fibrillation paroxysmal	0.23% 1/442 • Number of events 38
Cardiac disorders cardio-respiratory failure	0.23% 1/442 • Number of events 38
Nervous system disorders transient cerebral ischemia	0.23% 1/442 • Number of events 38
Nervous system disorders ischemic strocke	0.23% 1/442 • Number of events 38
Respiratory, thoracic and mediastinal disorders acute pulmonary edaema	0.45% 2/442 • Number of events 38
Respiratory, thoracic and mediastinal disorders Pneumothorax NOS	0.23% 1/442 • Number of events 38
Reproductive system and breast disorders Respiratort insufficiency	0.23% 1/442 • Number of events 38
Vascular disorders mesenteric ischemia	0.23% 1/442 • Number of events 38
General disorders malaise	0.23% 1/442 • Number of events 38
General disorders general physical health deterioration	0.45% 2/442 • Number of events 38

Other adverse events

Adverse event data not reported

Additional Information

Pr patrick MISMETTI

CHU SAINT-ETIENNE

Phone: 33(1)477127788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place