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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1. 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 2. 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 3. Adult patients (18 years of age and older) who underwent liver transplantation (recipients)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Awards & highlights
No Placebo-Only Group
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measure from the single blood draw was assessed within 2 hours of blood draw.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Method Comparison
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Liver TransplantExperimental Treatment2 Interventions
Group II: CV SurgeryExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TEG 6s Citrated K, KH, RTH, FFH Cartridge
2021
N/A
~340
Clauss Fibrinogen
2021
N/A
~520
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Who is running the clinical trial?
ClinStatDeviceUNKNOWN
1 Previous Clinical Trials
181 Total Patients Enrolled
Boston Healthcare Technologies Consultants, LLCUNKNOWN
Haemonetics CorporationLead Sponsor
19 Previous Clinical Trials
10,795 Total Patients Enrolled
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