Clinical Trials Logo
  1. Home
  2. Orthopedic Surgery
  3. NCT01063543
  4. Details
NCT01063543 Clinical Trial

Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

Orthopedic Surgery Clinical Trial

— POP-A-RIX  

Official title:
Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01063543
Other study ID # 0601069
Secondary ID
Status Completed
Phase N/A
First received February 4, 2010
Last updated February 4, 2010
Start date September 2004
Est. completion date February 2007

Study information
Verified date February 2010
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection Authority
Study type Observational

Clinical Trial Summary

Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies

Recruitment information / eligibility
Status Completed
Enrollment 997
Est. completion date February 2007
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- patient who need leg major orthopedic surgery

- age > 18 years

- patient who need prophylactic doses of fondaparinux

Exclusion Criteria:

- contra-indication to fondaparinux

- renal insufficiency

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CHARRET Françoise Annonay
France PEGOIX Michel Caen
France ROSENCHER Nadia Paris
France PETIT Pierre-Yves Pierre Bénite
France BARRE Jeanne Reims
France MAITRE Anne-Marie Rouen
France BAYLOT Denis Saint-etienne
France ZUFFEREY Paul Saint-etienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine an anti-Xa activity value which is predicted of a haemorrhage risk day 9 Yes
See also
  Status Clinical Trial Phase
Completed NCT03657368 - Ventilation Strategy During General Anesthesia for Orthopedic Surgery N/A
Withdrawn NCT02771041 - Assessment of the Influence of Early Preoperative Consultation on Satisfaction and the Average Length of Stay of Patients Who Underwent Total Hip Arthroplasty N/A
Completed NCT02278627 - Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement N/A
Recruiting NCT01205295 - Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment N/A
Completed NCT01389011 - Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery N/A
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Not yet recruiting NCT05537155 - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery N/A
Completed NCT03532256 - Post-op Crowd Sourcing Health Data Via Text-messaging
Active, not recruiting NCT03366805 - A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery N/A
Completed NCT03769077 - Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP N/A
Recruiting NCT05401058 - Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery N/A
Completed NCT00293631 - Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy Phase 2
Completed NCT05110690 - Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study N/A
Completed NCT05120739 - Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery N/A
Completed NCT00702416 - Ultrasound Guidance for Interscalene Brachial Plexus Block Phase 4
Completed NCT00724035 - Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery Phase 4
Completed NCT00192894 - New Methods to Detect a Decrease in Heart Function Phase 4
Completed NCT05424211 - The Effect of Music Therapy on Pain Level and Analgesic Consumption N/A
Withdrawn NCT00269971 - A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery. Phase 3
Completed NCT03430453 - Monitoring of Intensity of Stimulation and Injection Pressure in US Guided Peripheral Nerve Block According to Anatomic Needle Type Position N/A