Heparin-Coated Polyacrylonitrile Membrane Versus Regional Citrate Anticoagulation: A Prospective Randomized Study of 2 Anticoagulation Strategies in Patients at Risk of Bleeding

Abstract Background Recommended regular saline flushing presents clinical ineffectiveness for hemodialysis (HD) patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has previously been used with a Ca2+ containing dialysate with prefiltered citrate in one arm (RCA-one). However, anticoagulation is not always achievable and up to 40% results in serious clotting in the venous expansion chamber. In this study, we have transferred one-quarter of the TSC from the prefiltered to the post filter based on RCA-one, which we have called RCA-two. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk. Method In this investigator-initiated, multicenter, controlled, prospective, randomized clinical trial, 52 HD patients (77 sessions) were randomized to the RCA-2 and RCA-one group in part one of the trial, and 45 patients (64 sessions) were randomized to the RCA-2 and saline group in part two of the trial. Serious clotting events, adverse events and blood analyses were recorded. Results Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively). The median circuit survival time was 240 min (IQR 240 to 240) in the RCA-two group, was significantly longer than 230 min (IQR 155 to 240, P < 0.001) in the RCA-one group and 210 min (IQR 135 to 240, P = 0.003) in the saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the saline group and 10 patients (26.31%) in the RCA-two group, P > 0.05. Conclusions Our data demonstrated that the modified anticoagulation protocol was more effective and feasible during hemodialysis therapy for patients at high risk of bleeding. Trial registration GDREC, GDREC2017250H. Registered February 2, 2018; retrospectively registered.

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Modified regional citrate anticoagulation is optimal for hemodialysis in patients at high risk of bleeding: A prospective randomized study of three anticoagulation strategies

10.21203/rs.2.11875/v2 ◽

2019 ◽

Author(s):

Ting Lin ◽

Li Song ◽

Renwei Huang ◽

Ying Huang ◽

Shuifu Tang ◽

...

Keyword(s):

High Risk ◽

Randomized Study ◽

Bleeding Risk ◽

Saline Group ◽

Regional Citrate Anticoagulation ◽

Expansion Chamber ◽

Citrate Anticoagulation ◽

Risk Of Bleeding ◽

Group 4 ◽

High Bleeding Risk

Abstract ABSTRACT Background： Recommended regular saline flushing presents clinical ineffectiveness for hemodialysis (HD) patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has previously been used with a Ca 2+ containing dialysate with prefiltered citrate in one arm (RCA-one). However, anticoagulation is not always achievable and up to 40% results in serious clotting in the venous expansion chamber. In this study, we have transferred one-quarter of the TSC from the prefiltered to the post filter based on RCA-one, which we have called RCA-two. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk. Method ： In this investigator-initiated, multicenter, controlled, prospective, randomized clinical trial, 52 HD patients (77 sessions) were randomized to the RCA-two and RCA-one group in part one of the trial, and 45 patients (64 sessions) were randomized to the RCA-two and saline group in part two of the trial. Serious clotting events, adverse events and blood analyses were recorded. Results ：Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively). The median circuit survival time was 240 min (IQR 240 to 240) in the RCA-two group, was signiﬁcantly longer than 230 min (IQR 155 to 240, P < 0.001) in the RCA-one group and 210 min (IQR 135 to 240，P = 0.003) in the saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the saline group and 10 patients (26.31%) in the RCA-two group, P>0.05. Conclusions ： Our data demonstrated that the modified anticoagulation protocol was more effective and feasible during hemodialysis therapy for patients at high risk of bleeding. Trial registration: GDREC, GDREC2017250H. Registered February 2, 2018; prospectively registered.

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Su1219 Patient-Oriented Education and Visual-Aid Intervention Are Inadequate to Identify Patients at Risk of Capsule Retention: A Prospective Randomized Study

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2016.03.804 ◽

2016 ◽

Vol 83 (5) ◽

pp. AB316 ◽

Cited By ~ 1

Author(s):

Badr Al-Bawardy ◽

Shiv K. Desai ◽

David H. Bruining ◽

Christopher Gostout ◽

Stephanie L. Hansel ◽

...

Keyword(s):

At Risk ◽

Randomized Study ◽

Prospective Randomized Study ◽

Visual Aid ◽

Patients At Risk ◽

Capsule Retention

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Modified regional citrate anticoagulation is optimal for hemodialysis in patients at high risk of bleeding: A prospective randomized study of three anticoagulation strategies

10.21203/rs.2.11875/v3 ◽

2019 ◽

Author(s):

Ting Lin ◽

Li Song ◽

Renwei Huang ◽

Ying Huang ◽

Shuifu Tang ◽

...

Keyword(s):

High Risk ◽

Randomized Study ◽

Bleeding Risk ◽

Saline Group ◽

Regional Citrate Anticoagulation ◽

Expansion Chamber ◽

Citrate Anticoagulation ◽

Risk Of Bleeding ◽

Group 4 ◽

High Bleeding Risk

Abstract ABSTRACT Background： Recommended regular saline flushing presents clinical ineffectiveness for hemodialysis (HD) patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has previously been used with a Ca 2+ containing dialysate with prefiltered citrate in one arm (RCA-one). However, anticoagulation is not always achievable and up to 40% results in serious clotting in the venous expansion chamber. In this study, we have transferred one-quarter of the TSC from the prefiltered to the post filter based on RCA-one, which we have called RCA-two. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk. Method ： In this investigator-initiated, multicenter, controlled, prospective, randomized clinical trial, 52 HD patients (77 sessions) were randomized to the RCA-two and RCA-one group in part one of the trial, and 45 patients (64 sessions) were randomized to the RCA-two and saline group in part two of the trial. Serious clotting events, adverse events and blood analyses were recorded. Results ：Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively). The median circuit survival time was 240 min (IQR 240 to 240) in the RCA-two group, was signiﬁcantly longer than 230 min (IQR 155 to 240, P < 0.001) in the RCA-one group and 210 min (IQR 135 to 240，P = 0.003) in the saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the saline group and 10 patients (26.31%) in the RCA-two group, P>0.05. Conclusions ： Our data demonstrated that the modified anticoagulation protocol was more effective and feasible during hemodialysis therapy for patients at high risk of bleeding. Trial registration: GDREC, GDREC2017250H. Registered February 2, 2018; prospectively registered.

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Citrate Anticoagulation for Hemodialysis Patients at Risk of Bleeding

American Journal of Nephrology ◽

10.1159/000167977 ◽

1989 ◽

Vol 9 (3) ◽

pp. 263-264 ◽

Cited By ~ 2

Author(s):

Frederic E. Collart ◽

Christian L. Tielemans ◽

Robert Wens ◽

Max Dratwa

Keyword(s):

At Risk ◽

Hemodialysis Patients ◽

Citrate Anticoagulation ◽

Risk Of Bleeding ◽

Patients At Risk

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Modified regional citrate anticoagulation is optimal for hemodialysis in patients at high risk of bleeding: A prospective randomized study of three anticoagulation strategies

10.21203/rs.2.11875/v1 ◽

2019 ◽

Author(s):

Ting Lin ◽

Li Song ◽

Renwei Huang ◽

Ying Huang ◽

Shuifu Tang ◽

...

Keyword(s):

Clinical Trial ◽

High Risk ◽

Randomized Study ◽

Bleeding Risk ◽

Saline Group ◽

Regional Citrate Anticoagulation ◽

Expansion Chamber ◽

Citrate Anticoagulation ◽

Risk Of Bleeding ◽

High Bleeding Risk

Abstract Background：The recommended regular saline flushing presents clinical ineffectiveness for patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has been used in a Ca2+ containing dialysate with prefilter citrate in one arm (RCA-one). The anticoagulation effect was not realized, and up to 40% resulted in serious clotting in the venous expansion chamber. We innovatively transferred one-quarter of the TSC from the prefilter to the postfilter based on RCA-one, which is called RCA-two in this trial. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk. Method：In this investigator-initiated, multicenter, placebo-controlled, prospective, randomized clinical trial, 52 patients (77 sessions) were randomized to the RCA-two and RCA-one group in part one trial, and 45 patients (64 sessions) were randomized to the RCA-two and Saline group in part two trial. Serious clotting events, adverse events and blood analyses were recorded. Results：The primary outcome, Serious clotting events in the RCA-two group were significantly lower than that in the RCA-one and Saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively). The median circuit survival time was 240 min (IQR 240 to 240) in the RCA-two group, which was signiﬁcantly longer than 230 min (IQR 155 to 240, P < 0.001) in the RCA-one group and 210 min (IQR 135 to 240，P = 0.003) in the Saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the Saline group and 10 patients (26.31%) in the RCA-two group, P>0.05. Conclusions：Our data demonstrated that the modified anticoagulation protocol is more effective and feasible during hemodialysis therapy for patients at high risk of bleeding. Trial registration: GDREC, GDREC2017250H. Registered 2th February 2018-Retrospectively registered. Keywords: regional citrate anticoagulation, hemodialysis, high risk of bleeding, serious clotting, saline flushing, randomized prospective clinical trial.

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A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS

Reproductive BioMedicine Online ◽

10.1016/s1472-6483(10)60339-2 ◽

2007 ◽

Vol 15 (3) ◽

pp. 271-279 ◽

Cited By ~ 39

Author(s):

Mohamed A Aboulghar ◽

Ragaa T Mansour ◽

Yahia M Amin ◽

Hesham G Al-Inany ◽

Mona M Aboulghar ◽

...

Keyword(s):

At Risk ◽

Gnrh Antagonist ◽

Randomized Study ◽

Prospective Randomized Study ◽

Patients At Risk ◽

Severe Ohss

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Plasma Rivaroxaban Level to Identify Patients at Risk of Drug Overexposure: Is a Single Measurement of Drug Level Reliable?

TH Open ◽

10.1055/s-0040-1721734 ◽

2021 ◽

Vol 05 (01) ◽

pp. e84-e88

Author(s):

Krishnan Shyamkumar ◽

Jack Hirsh ◽

Vinai C. Bhagirath ◽

Jeffrey S. Ginsberg ◽

John W. Eikelboom ◽

...

Keyword(s):

At Risk ◽

Dose Reduction ◽

Dose Adjustment ◽

Trough Level ◽

Drug Level ◽

Single Measurement ◽

Risk Of Bleeding ◽

Level Measurement ◽

Patients At Risk ◽

Trough Levels

Abstract Introduction Dose adjustment based on laboratory monitoring is not routinely recommended for patients treated with rivaroxaban but because an association has been reported between high drug level and bleeding, it would be of interest to know if measuring drug level once could identify patients at risk of bleeding who might benefit from a dose reduction. Objective This study was aimed to investigate the reliability of a single measurement of rivaroxaban level to identify clinic patients with persistently high levels, defined as levels that remained in the upper quintile of drug-level distribution. Methods In this prospective cohort study of 100 patients with atrial fibrillation or venous thromboembolism, peak and trough rivaroxaban levels were measured using the STA-Liquid Anti-Xa assay at baseline and after 2 months. Values of 395.8 and 60.2 ng/mL corresponded to the 80th percentile for peak and trough levels, respectively, and levels above these cut-offs were categorized as high for our analyses. Results Among patients with a peak or trough level in the upper quintile at baseline, only 26.7% (95% confidence interval [CI]: 10.9–52.0%), and 13.3% (95% CI: 2.4–37.9%), respectively, remained above these thresholds. Conclusion Our findings do not support the use of a single rivaroxaban level measurement to identify patients who would benefit from a dose reduction because such an approach is unable to reliably identify patients with high levels.

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