Pilot, prospective, multicentre, open and non-randomised study: definition of an index of AntiXa value at the end of haemodialysis treatment
- Conditions
- Chronic renal failureUrological and Genital Diseases
- Registration Number
- ISRCTN93952087
- Lead Sponsor
- Gambro Lundia AB (Sweden)
- Brief Summary
2003 results in: https://www.ncbi.nlm.nih.gov/pubmed/13679486 (added 14/02/2019) 2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18156457 (added 14/02/2019) 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/22925178 (added 14/02/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Patients suffering from chronic renal failure
2. Patients treated in haemodialysis (HD) three times a week for at least 3 months, with a stable heparin dose and the same filter
3. Patients treated in 4 - 4.5 hours HD mode with a blood flow between 300 - 350 ml/min
4. Patients for whom either low molecular weight heparin (LMWH) (enoxaparin, nadroparin, tinzaparin) or unfractionated heparin (UFH) is used
5. Patients with a well-functioning vascular access as judged by the investigator
6. Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device
7. Patients older than 18 years, either sex
8. Patients with negative serologies (acquired immune deficiency syndrome [AIDS], hepatitis)
9. Patients having signed consent to participate in the study
1. Patient with heparin-induced thrombocytopenia (HIT) or known heparin allergy
2. Patient treated in HD in single needle mode
3. Patients with catheter
4. Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results
5. Patients participating in other studies that could interfere with the objective of this study
6. Patients with active malignant disease
7. Patients receiving heparin outside dialysis treatment
8. Patients under guardianship
9. Pregnant women, nursing mothers and women planning a pregnancy during the course of this study
10. Patients with serious history of coagulopathy
11. Patients receiving Anti-Vitamin K medication
12. Patients receiving an association of anti-platelets agents
13. Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect data to define a statistical index of Anti Xa (SIAX) value, at the end of HD treatment, performed without any coagulation issues.
- Secondary Outcome Measures
Name Time Method