Therapeutic Plasma ExchangeNCT04351438
Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
An observational study of Therapeutic Plasma Exchange and Anticoagulant Therapy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Despite its growing use across the world, and similar efficacy, filter-based therapeutic plasma exchange (TPE) continues to be used less often that centrifuge-based TPE. One of the reasons is that the patient and circuit complications of centrifuge-based TPE are familiar to the clinical team. Read more about this study
- Who is it for?
- Ages 0 to 24 years
- Conditions the study is for
- Therapeutic Plasma Exchange, Anticoagulant Therapy
- What is being tested?
- Active Comparator: centrifuge TPE with citrate, Active Comparator: Filter TPE with heparin and Active comparator: Filter TPE with citrate
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 4 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: retrospective database used to analyze subjects
Who may be able to join
- Patients who received therapeutic plasma exchange at Children's of Alabama between 2012 and 2019
Who cannot join
- Patients that received TPE with concomitant extra-corporeal membrane oxygenation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prismaflex Therapeutic Plasma Exchange: Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
Despite its growing use across the world, and similar efficacy, filter-based therapeutic plasma exchange (TPE) continues to be used less often that centrifuge-based TPE. One of the reasons is that the patient and circuit complications of centrifuge-based TPE are familiar to the clinical team. There is little data on the patient and circuit complications of filter-based TPE (using the Prismaflex). Furthermore, there is a reluctance to use filter-based TPE because historically, most TPE programs have used citrate-regional anticoagulation, and there is a large gap in knowledge in the use of citrate regional anti-coagulation when using filter-based TPE.
Read the detailed description
Studies that evaluate differences between filter-based vs. centrifuge based TPE are lacking. Heparin-based TPE is the most commonly used method of anti-coagulation when performing filter-based TPE. Citrate anticoagulation is FDA approved for use during TPE and its use is the gold-standard anti-coagulant method for TPE. However, citrate has not been studied rigorously in patients who are on filtration-based TPE on Prismaflex.
Providing citrate-based anticoagulation during TPE is challenging for several reasons. First, because calcium will bind to albumin, one must provide additional albumin in some way to prevent hypocalcemia. Second, when the replacement fluid is fresh frozen plasma (FFP), the clinician must account for a very large dose of citrate (which can be 3 times higher than the dose used to anti-coagulate whole blood) that is present in the FFP. Based on these principles, with clinical observations and experience using citrate-based continuous renal replacement therapy, this hospital developed a clinical protocol for use during filter-based TPE. This protocol has been in use since 2012 in the Renal Care Center at the Children's of Alabama.
As the use of filter-based TPE continue to rise, clinicians need evidence-based data to help them care for their patients. Although there are a few reports on the complication rates during centrifuge TPE, known, there are no published reports on the complication rate during filter-based TPE. A comparison of the complications rate between filter-based TPE and centrifuge TPE will help providers recognize the safety of filter-based TPE. There are no known regional citrate anticoagulation protocols for patients receiving filter-based TPE using Prismaflex. As the use of filter-based TPE continues to rise, there is a great need to fill this important knowledge gap. As more patients are cared in critical care arena, more clinicians will need evidence-based protocols for regional citrate anti-coagulation. This study will fill important gaps in knowledge that will improve the ability of clinical teams to provide filter-based TPE using Prismaflex.
- Conditions
- Therapeutic Plasma Exchange, Anticoagulant Therapy
- Being tested
- Active Comparator: centrifuge TPE with citrate, Active Comparator: Filter TPE with heparin, Active comparator: Filter TPE with citrate
- Keywords
- complications, heparin, citrate, membrane, filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: centrifuge TPE with citrateDevice
Patients who received citrate-based anticoagulation with centrifuge TPE
Active Comparator: Filter TPE with heparinDevice
Patients who received heparin-based anticoagulation with filter TPE
Active comparator: Filter TPE with citrateDrug
Patients who received citrate-based anticoagulation with filter TPE
| Study group | Role | What they receive |
|---|---|---|
| Centrifuge TPE with citrate | These participants were undergoing centrifuge TPE using citrate anticoagulant Receives: Device: Active Comparator: centrifuge TPE with citrate | |
| Filter TPE with heparin | These participants were undergoing filter TPE using filter-based heparin anticoagulant Receives: Device: Active Comparator: Filter TPE with heparin | |
| Filter TPE with citrate | These participants were undergoing filter TPE using filter-based citrate anticoagulant Receives: Drug: Active comparator: Filter TPE with citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient complications during TPE
patient-related complications during procedure
Measured: complications during any TPE procedure (3 hours to 400 days)
Secondary outcomes (1)
Percentage of circuit-related complications during TPE
circuit-related complications during procedure
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 2012
- Primary completion31 Dec 2019
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Therapeutic Plasma ExchangeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Askenazi, University of Alabama at Birmingham
- Investigators
- David Askenazi, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351438
- Sponsor's protocol ID
- 300003769
- Status last verified
- Feb 2024
- First submitted
- 10 Apr 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
PubMed 23394211Zhang W, Bai M, Yu Y, Li L, Zhao L, Sun S, Chen X. Safety and efficacy of regional citrate anticoagulation for continuous renal replacement therapy in liver failure patients: a systematic review and meta-analysis. Crit Care. 2019 Jan 24;23(1):22. doi: 10.1186/s13054-019-2317-9.
PubMed 30678706Meersch M, Kullmar M, Wempe C, Kindgen-Milles D, Kluge S, Slowinski T, Marx G, Gerss J, Zarbock A; SepNet Critical Care Trials Group. Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial. BMJ Open. 2019 Jan 21;9(1):e024411. doi: 10.1136/bmjopen-2018-024411.
PubMed 30670518Zhang C, Lin T, Zhang J, Liang H, Di Y, Li N, Gao J, Wang W, Liu S, Wang Z, Jiang H, Liu C. [Safety and efficacy of regional citrate anticoagulation in continuous renal replacement therapy in the presence of acute kidney injury after hepatectomy]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Aug;30(8):777-782. doi: 10.3760/cma.j.issn.2095-4352.2018.08.013. Chinese.
PubMed 30220281Rico MP, Fernandez Sarmiento J, Rojas Velasquez AM, Gonzalez Chaparro LS, Gastelbondo Amaya R, Mulett Hoyos H, Tibaduiza D, Quintero Gomez AM. Regional citrate anticoagulation for continuous renal replacement therapy in children. Pediatr Nephrol. 2017 Apr;32(4):703-711. doi: 10.1007/s00467-016-3544-9. Epub 2016 Nov 28.
PubMed 27896442Lee G, Arepally GM. Anticoagulation techniques in apheresis: from heparin to citrate and beyond. J Clin Apher. 2012;27(3):117-25. doi: 10.1002/jca.21222. Epub 2012 Apr 24.
PubMed 22532037Kankirawatana S, Huang ST, Marques MB. Continuous infusion of calcium gluconate in 5% albumin is safe and prevents most hypocalcemic reactions during therapeutic plasma exchange. J Clin Apher. 2007;22(5):265-9. doi: 10.1002/jca.20142.
PubMed 17722047Lemaire A, Parquet N, Galicier L, Boutboul D, Bertinchamp R, Malphettes M, Dumas G, Mariotte E, Peraldi MN, Souppart V, Schlemmer B, Azoulay E, Canet E. Plasma exchange in the intensive care unit: Technical aspects and complications. J Clin Apher. 2017 Dec;32(6):405-412. doi: 10.1002/jca.21529. Epub 2017 Feb 1.
PubMed 28146331
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prismaflex Therapeutic Plasma Exchange: Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
- ClinicalTrials.gov ID
- NCT04351438
- Acronym / sponsor ID
- 300003769
- Conditions
- Therapeutic Plasma Exchange, Anticoagulant Therapy
- Keywords
- complications, heparin, citrate, membrane, filter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite its growing use across the world, and similar efficacy, filter-based therapeutic plasma exchange (TPE) continues to be used less often that centrifuge-based TPE. One of the reasons is that the patient and circuit complications of centrifuge-based TPE are familiar to the clinical team. There is little data on the patient and circuit complications of filter-based TPE (using the Prismaflex). Furthermore, there is a reluctance to use filter-based TPE because historically, most TPE programs have used citrate-regional anticoagulation, and there is a large gap in knowledge in the use of citrate regional anti-coagulation when using filter-based TPE.
Detailed description
Studies that evaluate differences between filter-based vs. centrifuge based TPE are lacking. Heparin-based TPE is the most commonly used method of anti-coagulation when performing filter-based TPE. Citrate anticoagulation is FDA approved for use during TPE and its use is the gold-standard anti-coagulant method for TPE. However, citrate has not been studied rigorously in patients who are on filtration-based TPE on Prismaflex.
Providing citrate-based anticoagulation during TPE is challenging for several reasons. First, because calcium will bind to albumin, one must provide additional albumin in some way to prevent hypocalcemia. Second, when the replacement fluid is fresh frozen plasma (FFP), the clinician must account for a very large dose of citrate (which can be 3 times higher than the dose used to anti-coagulate whole blood) that is present in the FFP. Based on these principles, with clinical observations and experience using citrate-based continuous renal replacement therapy, this hospital developed a clinical protocol for use during filter-based TPE. This protocol has been in use since 2012 in the Renal Care Center at the Children's of Alabama.
As the use of filter-based TPE continue to rise, clinicians need evidence-based data to help them care for their patients. Although there are a few reports on the complication rates during centrifuge TPE, known, there are no published reports on the complication rate during filter-based TPE. A comparison of the complications rate between filter-based TPE and centrifuge TPE will help providers recognize the safety of filter-based TPE. There are no known regional citrate anticoagulation protocols for patients receiving filter-based TPE using Prismaflex. As the use of filter-based TPE continues to rise, there is a great need to fill this important knowledge gap. As more patients are cared in critical care arena, more clinicians will need evidence-based protocols for regional citrate anti-coagulation. This study will fill important gaps in knowledge that will improve the ability of clinical teams to provide filter-based TPE using Prismaflex.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Centrifuge TPE with citrate | – | Device: Active Comparator: centrifuge TPE with citrateThese participants were undergoing centrifuge TPE using citrate anticoagulant |
| Filter TPE with heparin | – | Device: Active Comparator: Filter TPE with heparinThese participants were undergoing filter TPE using filter-based heparin anticoagulant |
| Filter TPE with citrate | – | Drug: Active comparator: Filter TPE with citrateThese participants were undergoing filter TPE using filter-based citrate anticoagulant |
Who may qualify
- Ages
- 0 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- retrospective database used to analyze subjects
Key inclusion criteria (1 listed)
- Patients who received therapeutic plasma exchange at Children's of Alabama between 2012 and 2019
Key exclusion criteria (1 listed)
- Patients that received TPE with concomitant extra-corporeal membrane oxygenation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: centrifuge TPE with citratePatients who received citrate-based anticoagulation with centrifuge TPE | Device | Centrifuge TPE with citrate |
| Active Comparator: Filter TPE with heparinPatients who received heparin-based anticoagulation with filter TPE | Device | Filter TPE with heparin |
| Active comparator: Filter TPE with citratePatients who received citrate-based anticoagulation with filter TPE | Drug | Filter TPE with citrate |
Primary outcome
Percentage of patient complications during TPE
Time frame: complications during any TPE procedure (3 hours to 400 days)
patient-related complications during procedure
1 secondary outcome
Percentage of circuit-related complications during TPE
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Results publication: PubMed 23394211Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
- Results publication: PubMed 30678706Zhang W, Bai M, Yu Y, Li L, Zhao L, Sun S, Chen X. Safety and efficacy of regional citrate anticoagulation for continuous renal replacement therapy in liver failure patients: a systematic review and meta-analysis. Crit Care. 2019 Jan 24;23(1):22. doi: 10.1186/s13054-019-2317-9.
- Results publication: PubMed 30670518Meersch M, Kullmar M, Wempe C, Kindgen-Milles D, Kluge S, Slowinski T, Marx G, Gerss J, Zarbock A; SepNet Critical Care Trials Group. Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial. BMJ Open. 2019 Jan 21;9(1):e024411. doi: 10.1136/bmjopen-2018-024411.
- Results publication: PubMed 30220281Zhang C, Lin T, Zhang J, Liang H, Di Y, Li N, Gao J, Wang W, Liu S, Wang Z, Jiang H, Liu C. [Safety and efficacy of regional citrate anticoagulation in continuous renal replacement therapy in the presence of acute kidney injury after hepatectomy]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Aug;30(8):777-782. doi: 10.3760/cma.j.issn.2095-4352.2018.08.013. Chinese.
- Results publication: PubMed 27896442Rico MP, Fernandez Sarmiento J, Rojas Velasquez AM, Gonzalez Chaparro LS, Gastelbondo Amaya R, Mulett Hoyos H, Tibaduiza D, Quintero Gomez AM. Regional citrate anticoagulation for continuous renal replacement therapy in children. Pediatr Nephrol. 2017 Apr;32(4):703-711. doi: 10.1007/s00467-016-3544-9. Epub 2016 Nov 28.
- Results publication: PubMed 22532037Lee G, Arepally GM. Anticoagulation techniques in apheresis: from heparin to citrate and beyond. J Clin Apher. 2012;27(3):117-25. doi: 10.1002/jca.21222. Epub 2012 Apr 24.
- Results publication: PubMed 17722047Kankirawatana S, Huang ST, Marques MB. Continuous infusion of calcium gluconate in 5% albumin is safe and prevents most hypocalcemic reactions during therapeutic plasma exchange. J Clin Apher. 2007;22(5):265-9. doi: 10.1002/jca.20142.
- Results publication: PubMed 28146331Lemaire A, Parquet N, Galicier L, Boutboul D, Bertinchamp R, Malphettes M, Dumas G, Mariotte E, Peraldi MN, Souppart V, Schlemmer B, Azoulay E, Canet E. Plasma exchange in the intensive care unit: Technical aspects and complications. J Clin Apher. 2017 Dec;32(6):405-412. doi: 10.1002/jca.21529. Epub 2017 Feb 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Askenazi, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Plasma Exchange and Anticoagulant Therapy, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient complications during TPE (time frame: complications during any TPE procedure (3 hours to 400 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351438, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.