SurgeryNCT06352125
An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge
An observational study of Surgery, run by Haemonetics Corporation at 7 sites in United States.
Trial summary
This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- TEG 6s Citrated K, KH, RTH, FFH Cartridge and Clauss Fibrinogen
- How many people
- 338 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Dec 2021to 31 Jan 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications.
Who may be able to join
- Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications undergoing cardiovascular surgeries or liver transplantation (recipients):
- Adult patients (18 years of age and older) who underwent cardiovascular on-pump surgeries or procedures (e.g., CABG) who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
- Adult patients (18 years of age and older) who underwent not-on-pump cardiovascular surgeries (e.g., lead extraction) or cardiovascular procedures (e.g., minimally invasive valve or percutaneous cardiac procedures, such as PCI, LAAC, TAVR/TAVI) associated with the use of heparin who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
- Adult patients (18 years of age and older) who underwent liver transplantation (recipients)
Who cannot join
- Patients with hereditary chronic coagulation and/or bleeding disorders
- Patients with hereditary fibrinolytic bleeding disorders
- Patients deemed unfit for participation in the by the principal investigator
- Patients participating in another clinical that would not be scientifically or medically compatible with this trial
- Patients with currently altered coagulation due to the presence of oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran, warfarin)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado
Aurora, Colorado, 80045
Lifebridge Health (Sinai Hospital)
Baltimore, Maryland, 21215
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ochsner Clinic
New Orleans, Louisiana, 70121
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Texas Health Science Center - San Antonio
San Antonio, Texas, 78229
University of California - San Francisco
San Francisco, California, 94143
About this study
This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators.
- Conditions
- Surgery
- Being tested
- TEG 6s Citrated K, KH, RTH, FFH Cartridge, Clauss Fibrinogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEG 6s Citrated K, KH, RTH, FFH CartridgeDiagnostic test
The TEG® 6s uses the Global Hemostasis with Heparin Neutralization (HN) Cartridge to test the hemostasis properties of citrated blood samples using four different assays/reagents simultaneously, one in each of the four cartridge channels.
Clauss FibrinogenDiagnostic test
Diagnostic Test: Clauss Fibrinogen Fibrinogen, also known as Factor I, is a plasma protein that can be transformed by thrombin into a fibrin gel ("the clot"). Fibrinogen is synthesized in the liver and circulates in the plasma as a disulfide-bonded dimer of 3 subunit chains. The biological half-life of plasma fibrinogen is 3 to 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant | Not described Receives: Diagnostic Test: TEG 6s Citrated K, KH, RTH, FFH Cartridge; Diagnostic Test: Clauss Fibrinogen | |
| CV Surgery | Not described Receives: Diagnostic Test: TEG 6s Citrated K, KH, RTH, FFH Cartridge; Diagnostic Test: Clauss Fibrinogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Method Comparison
CK-MA TEG Parameter. Unit of measurement was mm.
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Method Comparison
CKH-MA TEG Parameter. Unit of measurement was mm.
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Method Comparison
CRTH-MA TEG Parameter. Unit of measurement was mm.
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Method Comparison
CFFH-MA TEG Parameter. Unit of measurement was mm.
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Method Comparison
CK-R TEG Parameter. Unit of measurement was minutes.
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Method Comparison
CKH-R TEG Parameter. Unit of measurement was minutes.
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Primary Method Comparison
CKH-LY30 TEG Parameter. Unit of measurement was percentage.
Measured: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start9 Dec 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinStatDevice, Boston Healthcare Technologies Consultants, LLC
- Responsible party
- Sponsor
- Investigators
- Jan Hartmann, MD, Study director, Haemonetics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352125
- Sponsor's protocol ID
- TP-CLN-100503
- Status last verified
- Feb 2023
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Adelmann D, Hartmann J, Moore HB, Yockelson SR, Dageforde LA, Chitilian H, Little MB, Bliden KP, Gurbel PA, Tantry US, Subramaniam K, Sakai T. TEG (R) 6s Heparin Neutralization Cartridge for Hemostatic Assessment of Patients Undergoing Cardiovascular Surgery. Anesthesiology. 2026 Jan 1;144(1):103-115. doi: 10.1097/ALN.0000000000005759. Epub 2025 Sep 18.
PubMed 40965969
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge
- ClinicalTrials.gov ID
- NCT06352125
- Acronym / sponsor ID
- TP-CLN-100503
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ClinStatDevice, Boston Healthcare Technologies Consultants, LLC
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 8 Apr 2024 (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.
This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant | – | Diagnostic Test: TEG 6s Citrated K, KH, RTH, FFH Cartridge, Diagnostic Test: Clauss Fibrinogen |
| CV Surgery | – | Diagnostic Test: TEG 6s Citrated K, KH, RTH, FFH Cartridge, Diagnostic Test: Clauss Fibrinogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications.
Key inclusion criteria (4 listed)
- Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications undergoing cardiovascular surgeries or liver transplantation (recipients):
- Adult patients (18 years of age and older) who underwent cardiovascular on-pump surgeries or procedures (e.g., CABG) who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
- Adult patients (18 years of age and older) who underwent not-on-pump cardiovascular surgeries (e.g., lead extraction) or cardiovascular procedures (e.g., minimally invasive valve or percutaneous cardiac procedures, such as PCI, LAAC, TAVR/TAVI) associated with the use of heparin who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
- Adult patients (18 years of age and older) who underwent liver transplantation (recipients)
Key exclusion criteria (5 listed)
- Patients with hereditary chronic coagulation and/or bleeding disorders
- Patients with hereditary fibrinolytic bleeding disorders
- Patients deemed unfit for participation in the by the principal investigator
- Patients participating in another clinical that would not be scientifically or medically compatible with this trial
- Patients with currently altered coagulation due to the presence of oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran, warfarin)
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 |
|---|---|---|
| TEG 6s Citrated K, KH, RTH, FFH CartridgeThe TEG® 6s uses the Global Hemostasis with Heparin Neutralization (HN) Cartridge to test the hemostasis properties of citrated blood samples using four different assays/reagents simultaneously, one in each of the four cartridge channels. | Diagnostic test | CV Surgery, Liver Transplant |
| Clauss FibrinogenDiagnostic Test: Clauss Fibrinogen Fibrinogen, also known as Factor I, is a plasma protein that can be transformed by thrombin into a fibrin gel ("the clot"). Fibrinogen is synthesized in the liver and circulates in the plasma as a disulfide-bonded dimer of 3 subunit chains. The biological half-life of plasma fibrinogen is 3 to 5 days. | Diagnostic test | CV Surgery, Liver Transplant |
Primary outcome
Primary Method Comparison
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CK-MA TEG Parameter. Unit of measurement was mm.
Primary Method Comparison
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CKH-MA TEG Parameter. Unit of measurement was mm.
Primary Method Comparison
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CRTH-MA TEG Parameter. Unit of measurement was mm.
Primary Method Comparison
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CFFH-MA TEG Parameter. Unit of measurement was mm.
Primary Method Comparison
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CK-R TEG Parameter. Unit of measurement was minutes.
Primary Method Comparison
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CKH-R TEG Parameter. Unit of measurement was minutes.
Primary Method Comparison
Time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CKH-LY30 TEG Parameter. Unit of measurement was percentage.
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 Apr 2024.
- Derived from this study: PubMed 40965969Adelmann D, Hartmann J, Moore HB, Yockelson SR, Dageforde LA, Chitilian H, Little MB, Bliden KP, Gurbel PA, Tantry US, Subramaniam K, Sakai T. TEG (R) 6s Heparin Neutralization Cartridge for Hemostatic Assessment of Patients Undergoing Cardiovascular Surgery. Anesthesiology. 2026 Jan 1;144(1):103-115. doi: 10.1097/ALN.0000000000005759. Epub 2025 Sep 18.
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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.
Jan Hartmann, MD study director
Haemonetics Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Haemonetics Corporation at 7 sites 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 4 inclusion and 5 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Primary Method Comparison (time frame: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.). The study lists 7 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 NCT06352125, which also lists 1 linked publication.
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 Apr 2024.