Coagulation in Liver TransplantationNCT04282889
Rotational Thromboelastometry (ROTEM) TRUE-NATEM Reference Value Validation in Liver Transplantation
An observational study of Coagulation in Liver Transplantation, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Background: Rotational thromboelastometry (ROTEM) has been used widely in liver transplantation for coagulation management. However, a TRUE-NATEM (TRUE-Non-Activated Rotational Thromboelastometry) reference value has never been established. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation in Liver Transplantation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 1 Feb 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include 20 adults (age range of 18 - 75 years) who are undergoing liver transplantation.
Who may be able to join
- Inclusion criteria are patients undergoing liver transplantation with English as their native language.
Who cannot join
- Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed consents will be obtained from the patients who agree to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Background: Rotational thromboelastometry (ROTEM) has been used widely in liver transplantation for coagulation management. However, a TRUE-NATEM (TRUE-Non-Activated Rotational Thromboelastometry) reference value has never been established. A TRUE-NATEM value is of clinical significance since no coagulation activators or reagents will be added to the blood sample for analysis. Therefore, the result will reflect the true coagulation profile of the patient.
Methods: Non-citrated whole blood will be used for analysis. Blood will be drawn from the patient and transferred into a plastic reagent cup that has no reagent. Test will be performed within 4 minutes of blood draw to avoid activation of coagulation. Primary outcome measure will be clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF). The specific aims of the study are to establish a TRUE-NATEM reference value using Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation. Our hypothesis is that clotting time (CT), clot formation time (CFT) is prolonged and maximum clot firmness (MCF) decreased compared to healthy volunteers in patient undergoing liver transplantation due to synthetic coagulation factor deficiency.
Read the detailed description
This study is a prospective cohort study establishing a TRUE-NATEM reference value using Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation.
The study population will include 20 adults (age range of 18 - 75 years) who are undergoing liver transplantation. Inclusion criteria are patients undergoing liver transplantation with English as their native language.
Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed consents will be obtained from the patients who agree to participate in this clinical study.
Currently, all patients undergoing liver transplantation will have hourly ROTEM analysis as standard of care. An additional TRUE-NATEM test will be performed after induction if anesthesia. 5 mL of whole blood will be obtained via a preexisting peripheral IV catheter or arterial line using a sterile technique. The blood will be transferred into a plastic reagent cup that has no additives. Test will be performed within 4 minutes of blood draw.3 All patients will undergo the standard anesthesia care and intraoperative coagulation monitoring and blood transfusion will be carried out using the standard practice guideline of the TJUH.
The control population will include 20 adult volunteers (age 18-65 years) who meet the in the American Society of Anesthesiologists (ASA) Physical Status (PS) Classes 1 criteria. Exclusion criteria will be refusal, volunteers on any medication or significant history of bleeding.
In the control group 5 mL of whole blood will be obtained after placing a peripheral IV catheter using a sterile technique. Blood draw from steel needle will be avoided because steel will activate coagulation. The blood will be transferred into a plastic reagent cup that has no additives. Test will be performed within 4 minutes of blood draw.
For each patient and control group four channels of ROTEM (TRUE-NATEM, NATEM, INTEM, EXTEM,) will be performed following the standard guideline at the Anesthesiology Coagulation Laboratory by a certified ROTEM specialists. Primary outcome measure will be clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF). The following demographic information will be collected; ASA physical status, age, height, weight, gender, home medication use, past medical history, and past surgical history.
- Conditions
- Coagulation in Liver Transplantation
- Keywords
- ROTEM, Rotational Thromboelastometry, NATEM, TRUE-NATEM, Coagulation, liver transplantation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation group | The study population will include 20 adults (age range of 18 - 75 years) who are undergoing liver transplantation. Inclusion criteria are patients undergoing liver transplantation with English as their native language. Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed consents will be obtained from the patients who agree to participate in this clinical study. | |
| Healthy volunteer | The control population will include 20 adult volunteers (age 18-65 years) who meet the in the American Society of Anesthesiologists (ASA) Physical Status (PS) Classes 1 criteria. Exclusion criteria will be refusal, volunteers on any medication or significant history of bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clotting time (CT)
clotting time (CT) in seconds
Measured: 1 year
clot formation time (CFT)
clot formation time (CFT) in seconds
Measured: 1 year
maximum clot firmness (MCF)
maximum clot firmness (MCF) in mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start6 Oct 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coagulation in Liver TransplantationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282889
- Sponsor's protocol ID
- 20D.086
- Status last verified
- Apr 2021
- First submitted
- 18 Feb 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang YG, Martin DJ, Marquez J, Lewis JH, Bontempo FA, Shaw BW Jr, Starzl TE, Winter PM. Intraoperative changes in blood coagulation and thrombelastographic monitoring in liver transplantation. Anesth Analg. 1985 Sep;64(9):888-96.
PubMed 3896028Durila M. Nonactivated thromboelastometry able to detect fibrinolysis in contrast to activated methods (EXTEM, INTEM) in a bleeding patient. Blood Coagul Fibrinolysis. 2016 Oct;27(7):828-830. doi: 10.1097/MBC.0000000000000479.
PubMed 26656899Meesters MI, Koch A, Kuiper G, Zacharowski K, Boer C. Instability of the non-activated rotational thromboelastometry assay (NATEM) in citrate stored blood. Thromb Res. 2015 Aug;136(2):481-3. doi: 10.1016/j.thromres.2015.05.026. Epub 2015 May 27.
PubMed 26044665
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Thromboelastometry (ROTEM) TRUE-NATEM Reference Value Validation in Liver Transplantation
- ClinicalTrials.gov ID
- NCT04282889
- Acronym / sponsor ID
- 20D.086
- Conditions
- Coagulation in Liver Transplantation
- Keywords
- ROTEM, Rotational Thromboelastometry, NATEM, TRUE-NATEM, Coagulation, liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 25 Feb 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.
Background: Rotational thromboelastometry (ROTEM) has been used widely in liver transplantation for coagulation management. However, a TRUE-NATEM (TRUE-Non-Activated Rotational Thromboelastometry) reference value has never been established. A TRUE-NATEM value is of clinical significance since no coagulation activators or reagents will be added to the blood sample for analysis. Therefore, the result will reflect the true coagulation profile of the patient.
Methods: Non-citrated whole blood will be used for analysis. Blood will be drawn from the patient and transferred into a plastic reagent cup that has no reagent. Test will be performed within 4 minutes of blood draw to avoid activation of coagulation. Primary outcome measure will be clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF). The specific aims of the study are to establish a TRUE-NATEM reference value using Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation. Our hypothesis is that clotting time (CT), clot formation time (CFT) is prolonged and maximum clot firmness (MCF) decreased compared to healthy volunteers in patient undergoing liver transplantation due to synthetic coagulation factor deficiency.
Detailed description
This study is a prospective cohort study establishing a TRUE-NATEM reference value using Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation.
The study population will include 20 adults (age range of 18 - 75 years) who are undergoing liver transplantation. Inclusion criteria are patients undergoing liver transplantation with English as their native language.
Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed consents will be obtained from the patients who agree to participate in this clinical study.
Currently, all patients undergoing liver transplantation will have hourly ROTEM analysis as standard of care. An additional TRUE-NATEM test will be performed after induction if anesthesia. 5 mL of whole blood will be obtained via a preexisting peripheral IV catheter or arterial line using a sterile technique. The blood will be transferred into a plastic reagent cup that has no additives. Test will be performed within 4 minutes of blood draw.3 All patients will undergo the standard anesthesia care and intraoperative coagulation monitoring and blood transfusion will be carried out using the standard practice guideline of the TJUH.
The control population will include 20 adult volunteers (age 18-65 years) who meet the in the American Society of Anesthesiologists (ASA) Physical Status (PS) Classes 1 criteria. Exclusion criteria will be refusal, volunteers on any medication or significant history of bleeding.
In the control group 5 mL of whole blood will be obtained after placing a peripheral IV catheter using a sterile technique. Blood draw from steel needle will be avoided because steel will activate coagulation. The blood will be transferred into a plastic reagent cup that has no additives. Test will be performed within 4 minutes of blood draw.
For each patient and control group four channels of ROTEM (TRUE-NATEM, NATEM, INTEM, EXTEM,) will be performed following the standard guideline at the Anesthesiology Coagulation Laboratory by a certified ROTEM specialists. Primary outcome measure will be clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF). The following demographic information will be collected; ASA physical status, age, height, weight, gender, home medication use, past medical history, and past surgical history.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation group | – | –The study population will include 20 adults (age range of 18 - 75 years) who are undergoing liver transplantation. Inclusion criteria are patients undergoing liver transplantation with English as their native language. Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed consents will be obtained from the patients who agree to participate in this clinical study. |
| Healthy volunteer | – | –The control population will include 20 adult volunteers (age 18-65 years) who meet the in the American Society of Anesthesiologists (ASA) Physical Status (PS) Classes 1 criteria. Exclusion criteria will be refusal, volunteers on any medication or significant history of bleeding. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 20 adults (age range of 18 - 75 years) who are undergoing liver transplantation.
Key inclusion criteria (1 listed)
- Inclusion criteria are patients undergoing liver transplantation with English as their native language.
Key exclusion criteria (1 listed)
- Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed consents will be obtained from the patients who agree to participate in this clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clotting time (CT)
Time frame: 1 year
clotting time (CT) in seconds
clot formation time (CFT)
Time frame: 1 year
clot formation time (CFT) in seconds
maximum clot firmness (MCF)
Time frame: 1 year
maximum clot firmness (MCF) in mm
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 6 Apr 2021.
- Results publication: PubMed 3896028Kang YG, Martin DJ, Marquez J, Lewis JH, Bontempo FA, Shaw BW Jr, Starzl TE, Winter PM. Intraoperative changes in blood coagulation and thrombelastographic monitoring in liver transplantation. Anesth Analg. 1985 Sep;64(9):888-96.
- Results publication: PubMed 26656899Durila M. Nonactivated thromboelastometry able to detect fibrinolysis in contrast to activated methods (EXTEM, INTEM) in a bleeding patient. Blood Coagul Fibrinolysis. 2016 Oct;27(7):828-830. doi: 10.1097/MBC.0000000000000479.
- Results publication: PubMed 26044665Meesters MI, Koch A, Kuiper G, Zacharowski K, Boer C. Instability of the non-activated rotational thromboelastometry assay (NATEM) in citrate stored blood. Thromb Res. 2015 Aug;136(2):481-3. doi: 10.1016/j.thromres.2015.05.026. Epub 2015 May 27.
- Individual participant dataSharing planned: Undecided
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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.
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 Coagulation in Liver Transplantation, run by Thomas Jefferson University 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 6 Apr 2021. 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?
clotting time (CT) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT04282889, which also lists 3 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 6 Apr 2021.