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NCT04297839
Evaluation of Regional Anticoagulation With Citrate in Extended Hemodialysis
Phase 3 trial testing Citrate Anticoagulation Solution in Hemodialysis Complication in 200 participants. Suspended.
31 July 2022
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 12 February 2019 |
| Primary completion | 31 July 2022 |
| Estimated completion | 31 July 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Citrate Anticoagulation Solution
- Control Group (heparin or continuous saline) — full drug profile →
Conditions studied
- Hemodialysis Complication — all drugs for Hemodialysis Complication →
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
- Anticoagulant Toxicity — all drugs for Anticoagulant Toxicity →
Sponsor
University of Sao Paulo General Hospital
Who can join
18 and older, any sex, with Hemodialysis Complication or Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Data on regional citrate anticoagulation in patients with acute kidney injury (AKI) treated by hybrid or extended dialysis are scarce and heterogeneous. The path batch system (Genius®) or the proportion hemodialysis machines are well suited equipments to perform extended dialysis. However, clotting of the system might occur with relatively high frequency, especially in critically ill patients with high risk of clotting or in those with contraindication to the use of heparin. The aims of this study are: 1) to test and to validate a new protocol using citrate to perform regional anticoagulation in AKI patients admitted to the intensive care unit (ICU) and treated by extended dialysis, using a control group (use of heparin or intermittent saline flush) as comparison in the Heart Institute of the university medical complex "Clinics Hospital Medical School at São Paulo" (Hospital das Clínicas da Faculdade de Medicina do Estado de São Paulo) and at the Cancer Institute of the São Paulo State; 2) to evaluate the anticoagulation in these procedures with citrate and compare with the control group using heparin or saline flush, so the primary end point would be the rates of system clotting; 3) to study the calcium mass transfer in these procedures and its impact on bone metabolism in these patients. The inclusion criteria are all AKI patients admitted in these places and candidates to renal replacement therapy using the extended dialysis, age above 18 years. The exclusion criteria are acute liver failure, hemorrhagic stroke, platelets level below 20,000/mm3, and active bleeding needing transfusional support (two or more red cell packs in 24 hours).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04297839
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04297839 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo General Hospital
- Last refreshed: 5 October 2021
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