Trial Outcomes & Findings for Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy (NCT NCT02457403)
NCT ID: NCT02457403
Last Updated: 2021-01-22
Results Overview
Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).
Results posted on
2021-01-22
Participant Flow
This is a prospective, single center, randomized clinical trial. 34 controls had transfusions guided by conventional labs and 34 participants had transfusions guided by ROTEM during orthotopic liver transplantation.
Participant milestones
| Measure |
ROTEM
Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.
|
Conventional
Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Raw data was not available so this was the most efficient way to fulfill the "total" column, and there were only 34 participants in each arm.
Baseline characteristics by cohort
| Measure |
ROTEM
n=34 Participants
Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets \& 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.
|
Conventional
n=34 Participants
Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at \< 100 mg/dL, 1 unit of cryoprecipitate was also transfused.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
34 Participants
n=34 Participants
|
34 Participants
n=34 Participants
|
68 Participants
n=68 Participants
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=34 Participants
|
12 Participants
n=34 Participants
|
25 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=34 Participants
|
22 Participants
n=34 Participants
|
43 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity : White
|
31 Participants
n=34 Participants
|
31 Participants
n=34 Participants
|
62 Participants
n=68 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity : Non-white
|
3 Participants
n=34 Participants
|
3 Participants
n=34 Participants
|
6 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=34 Participants
|
34 Participants
n=34 Participants
|
68 Participants
n=68 Participants
|
|
Indication for OLT
|
34 Participants
n=34 Participants
|
34 Participants
n=34 Participants
|
68 Participants
n=68 Participants
|
|
Model for End-Stage Liver Disease Scale (MELD) score
ROTEM
|
25 units on a scale
STANDARD_DEVIATION 8.37 • n=34 Participants • Raw data was not available so this was the most efficient way to fulfill the "total" column, and there were only 34 participants in each arm.
|
—
|
25 units on a scale
STANDARD_DEVIATION 8.37 • n=34 Participants • Raw data was not available so this was the most efficient way to fulfill the "total" column, and there were only 34 participants in each arm.
|
|
Model for End-Stage Liver Disease Scale (MELD) score
Conventional
|
—
|
22 units on a scale
STANDARD_DEVIATION 7.70 • n=34 Participants • Raw data was not available so this was the most efficient way to fulfill the "total" column, and there were only 34 participants in each arm.
|
22 units on a scale
STANDARD_DEVIATION 7.70 • n=34 Participants • Raw data was not available so this was the most efficient way to fulfill the "total" column, and there were only 34 participants in each arm.
|
|
Presence of hepatocellular carcinoma
|
13 Participants
n=34 Participants
|
10 Participants
n=34 Participants
|
23 Participants
n=68 Participants
|
|
Presence of portal vein thrombosis
|
4 Participants
n=34 Participants
|
2 Participants
n=34 Participants
|
6 Participants
n=68 Participants
|
|
Presence of hypercoaguable state
|
0 Participants
n=34 Participants
|
2 Participants
n=34 Participants
|
2 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.
Outcome measures
| Measure |
ROTEM
n=34 Participants
Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets \& 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.
|
Conventional
n=34 Participants
Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at \< 100 mg/dL, 1 unit of cryoprecipitate was also transfused.
|
|---|---|---|
|
Intra-operative Blood Loss
|
2000 milliliters
Interval 1500.0 to 3375.0
|
3000 milliliters
Interval 2000.0 to 7750.0
|
SECONDARY outcome
Timeframe: Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months).
Outcome measures
| Measure |
ROTEM
n=34 Participants
Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets \& 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.
|
Conventional
n=34 Participants
Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at \< 100 mg/dL, 1 unit of cryoprecipitate was also transfused.
|
|---|---|---|
|
Number of Participants With Bleeding Events
|
1 participants
|
0 participants
|
Adverse Events
ROTEM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place