A pilot study regarding regional anticoagulation by a citrate containing dialysis fluid.
- Conditions
- bleeding and clottinghemodialysis1006447710029149
- Registration Number
- NL-OMON41845
- Lead Sponsor
- Albert Schweitzer Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Stable hemodialysis patients older than 18 years using acenocoumarol, fenprocoumon, acetylsalicylzuur, dipyridamol, clopidrogel, prasugrel or combinations of these.
Exclusion Criteria
Inability to give informed consent. Hemodialysis patients who have unstable dialysis sessions i.e. hypotensive periods, muscular cramps or patients who have an increased risk of these afflictions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study objective:<br /><br><br /><br>Does RCA prevent the increased anticoagulation in the patient as seen with LMWH?<br /><br><br /><br>Primary outcome:<br /><br><br /><br>The RCA as proposed prevents a change in TEG in the patient during and after<br /><br>the dialysis session as seen in conventional anticoagulation with LMWH. Due to<br /><br>the small number of observations, hard endpoints like clinical relevant bleeds<br /><br>or the number of blood transfusions will seldom occur. Therefore, these are not<br /><br>used as primary outcome points.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study objectives:<br /><br><br /><br>1. Does RCA cause an anticoagulation of the extracorporeal system comparable to<br /><br>LMWH?<br /><br><br /><br>2. Are serum Ca- and Mg-values after dialysis comparable to those with a<br /><br>conventional anticoagulation with LMWH and a 1.5 and 0.75 mmil/l containing<br /><br>dialysis fluid?<br /><br><br /><br><br /><br>The secondary endpoints:<br /><br><br /><br>1. During the proposed RCA clotting necessitating termination of the treatment<br /><br>session does not happen more frequently compared to LMWH. The number of signs<br /><br>of clotting in the extracorporeal system is not more frequent in the proposed<br /><br>RCA compared to LMWH.<br /><br><br /><br>2. The proposed RCA does not result in a rise in APTT ratio and increase<br /><br>thrombin time in the patient during and after a dialyse session, compared to<br /><br>conservative anticoagulantia with LMWH<br /><br><br /><br>3. The serum values of Ca and Mg are similar in both methods.</p><br>