Status:
TERMINATED
INR-Triggered Transfusion In GI Bleeders From ER
Lead Sponsor:
University of Colorado, Denver
Conditions:
Respiratory Distress Syndrome, Adult
Gastrointestinal Hemorrhage
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Transfusion-related acute lung injury (TRALI) is the most common cause of transfusion-related morbidity and mortality in the United States. It is very common and often unrecognized in the critically i...
Detailed Description
Advances in the understanding of the coagulation imbalance in liver disease have experts questioning the clinical efficacy of current plasma transfusion practices in patients with liver disease. Havin...
Eligibility Criteria
Inclusion
- Subjects will be eligible to participate in the study if they meet all of the following criteria:
- Admit to an ICU due to gastrointestinal bleeding AND an INR in first 12 hours \>1.8; (INR ≥ 1.6 if received ≥ 2 units plasma)
- Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:
- Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis of cirrhosis
- Signs of portal hypertension (ascites, varices, hypersplenism)
- Laboratory evidence of synthetic dysfunction (INR\>1.5, Bilirubin\> 2.0, Albumin\< 2.5) AND ≥2 physical exam findings on admission associated with chronic liver disease (palmar erythema, spider angiomata, asterixis, caput medusa, gynecomastia)
Exclusion
- Subjects will be ineligible to participate in the study if they meet any of the following criteria:
- Patient under age 18 OR pregnant OR incarcerated
- Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2\<165)41
- Patient admitted to ICU for re-bleed on same hospital admission OR has already received \>4 units of plasma.
- Patient already underwent therapeutic endoscopy with noted hemostasis
- History of inheritable or acquired clotting or bleeding disorder (hemophilia A or B or acquired clotting factor inhibitor)
- Patient is being actively anticoagulated with vitamin K antagonists, direct thrombin inhibitors, heparins or anti-Xa antagonists
- Inability to obtain consent OR clinical team believes one of the transfusion strategies will be harmful to the patient
- Congestive heart failure (previous clinical diagnosis or Ejection Fraction (EF) \<50%)
- Patient is do-not-resuscitate (DNR) or unexpected to live \> 72 hours
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01461889
Start Date
July 1 2011
End Date
August 1 2015
Last Update
March 27 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
2
Denver Health Hospitals
Denver, Colorado, United States, 80204