End Stage Renal DiseaseNCT03275077
To Compare TEG (Thrombelastography) and Conventional Tests in CKD Patients
An observational study of End Stage Renal Disease and Coagulopathy, run by Institute of Liver and Biliary Sciences, India.
Trial summary
Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, RBC etc. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease, Coagulopathy
- What is being tested?
- Thromboelastography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2016to 22 Dec 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 100 patients were recruited for the study based on the above criteria.Following enrollment, patients were divided into two groups as follows Group 1(Control Group): 50 patients who were healthy voluntary donors belonging to ASA PSI or ASA PSII Group 2(ESRD Group): 50 patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012) who never received renal replacement therapy (RRT
Who may be able to join
- Healthy voluntary donors belonging to ASA PSI or ASA PSII
- Patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012 ) who never received renal replacement therapy (RRT)
Who cannot join
- Patients on antiplatelet drugs, erythropoietin, desmopressin
- Patients with known bleeding disorders like haemophilia, aplastic anaemia etc
- Patients having coexisting liver diseases
- Patients on dialysis
- Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months
- Patients less than 18 years of age
- Pregnant patients
- Malignancy
About this study
Official title: A Comparative Evaluation of Thromboelastogram and Conventional Coagulation Tests To Detect Coagulopathy in End Stage Renal Disease Patients
Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients and compared it to CCTs and to controls.
Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.
- Conditions
- End Stage Renal Disease, Coagulopathy
- Being tested
- Thromboelastography
- Keywords
- End stage renal disease, ESRD, Thromboelastography, Fibrinogen
- Medical subject headings
- Kidney Failure, Chronic, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDevice
A viscoelastic test of coagulation
| Study group | Role | What they receive |
|---|---|---|
| Controls | Normal Healthy Volunteers Receives: Device: Thromboelastography | |
| ESRD patients | Patients with ESRD who have not received hemodialysis. Patients with known bleeding disorders, coexisting liver diseases, those who were on antiplatelet or anticoagulant therapy and patients who had received red blood cells, fresh frozen plasma or platelet transfusions in the past three months were excluded from the study. Receives: Device: Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.
Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.
Measured: 0 hr
Secondary outcomes (1)
To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease
the maximum amplitude obtained on an thromboelastography denotes clot strength which depends on platelet count and fibrinogen levels. thus an attempt will be made to corelate these values with fibrinogen levels and platelet count.
Measured: 0 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start12 Mar 2016
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kelika Prakash, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275077
- Sponsor's protocol ID
- ILBS-TEG-001
- Status last verified
- Jun 2018
- First submitted
- 16 Aug 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Thromboelastogram and Conventional Coagulation Tests To Detect Coagulopathy in End Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT03275077
- Acronym / sponsor ID
- ILBS-TEG-001
- Conditions
- End Stage Renal Disease, Coagulopathy
- Keywords
- End stage renal disease, ESRD, Thromboelastography, Fibrinogen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 12 Mar 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 7 Sep 2017 (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.
Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients and compared it to CCTs and to controls.
Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Device: ThromboelastographyNormal Healthy Volunteers |
| ESRD patients | – | Device: ThromboelastographyPatients with ESRD who have not received hemodialysis. Patients with known bleeding disorders, coexisting liver diseases, those who were on antiplatelet or anticoagulant therapy and patients who had received red blood cells, fresh frozen plasma or platelet transfusions in the past three months were excluded from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 100 patients were recruited for the study based on the above criteria.Following enrollment, patients were divided into two groups as follows Group 1(Control Group): 50 patients who were healthy voluntary donors belonging to ASA PSI or ASA PSII Group 2(ESRD Group): 50 patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012) who never received renal replacement therapy (RRT
Key inclusion criteria (2 listed)
- Healthy voluntary donors belonging to ASA PSI or ASA PSII
- Patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012 ) who never received renal replacement therapy (RRT)
Key exclusion criteria (8 listed)
- Patients on antiplatelet drugs, erythropoietin, desmopressin
- Patients with known bleeding disorders like haemophilia, aplastic anaemia etc
- Patients having coexisting liver diseases
- Patients on dialysis
- Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months
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 |
|---|---|---|
| ThromboelastographyA viscoelastic test of coagulation | Device | Controls, ESRD patients |
Primary outcome
To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.
Time frame: 0 hr
Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.
1 secondary outcome
To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease
Time frame: 0 hr
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 12 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Coagulopathy, run by Institute of Liver and Biliary Sciences, India.
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 2 inclusion and 8 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls. (time frame: 0 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2018.