Trial Outcomes & Findings for Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery (NCT NCT02758184)
NCT ID: NCT02758184
Last Updated: 2022-04-27
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
during surgery (up to approximately 10 hours)
Results posted on
2022-04-27
Participant Flow
Participant milestones
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery
Baseline characteristics by cohort
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 14.0 • n=99 Participants
|
61.2 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
60.6 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: during surgery (up to approximately 10 hours)Outcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Estimated Blood Loss (mL)
|
2318.8 mL
Standard Deviation 1629.3
|
3350.0 mL
Standard Deviation 1494.6
|
PRIMARY outcome
Timeframe: up to 48 hours after surgeryOutcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused
|
2.81 units of PRBCs
Standard Deviation 1.99
|
5.00 units of PRBCs
Standard Deviation 3.59
|
SECONDARY outcome
Timeframe: typically 5-7 daysOutcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Length of Hospital Stay After Surgery
|
6.3 days
Standard Deviation 1.4
|
6.2 days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: during surgery (up to approximately 10 hours)Outcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Cost Analysis, as Measured by Total Dollar Value of Blood Products Used
|
1123.00 US dollars
Standard Deviation 1078.60
|
1998.70 US dollars
Standard Deviation 2020.70
|
SECONDARY outcome
Timeframe: during surgery (up to approximately 10 hours)Outcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Amount of Recovered Blood Transfused During the Procedure (mL)
|
476.3 mL
Standard Deviation 434.3
|
879.4 mL
Standard Deviation 755.1
|
SECONDARY outcome
Timeframe: first 24 hours after surgeryOutcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Drain Output (mL)
|
587.5 mL
Standard Deviation 362.7
|
757.8 mL
Standard Deviation 335.3
|
SECONDARY outcome
Timeframe: during surgery (up to approximately 10 hours)Outcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Amount of Blood Products Transfused, Measured in Units
|
4.81 units of blood product
Standard Deviation 4.68
|
7.80 units of blood product
Standard Deviation 8.30
|
SECONDARY outcome
Timeframe: 48 hours following surgeryOutcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Amount of Blood Products Transfused, Measured in Units
|
0.54 units of blood product
Standard Deviation 0.93
|
1.20 units of blood product
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)Reporting the change in hemoglobin from baseline to approximately 10 hours.
Outcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Change in Hemoglobin (g/dL)
|
-2.56 g/dL
Standard Deviation 1.74
|
-2.78 g/dL
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)Reporting the change in platelet count from baseline to approximately 10 hours.
Outcome measures
| Measure |
Rotational Thrombo-elastometry (ROTEM) Group
n=11 Participants
Patients who are randomized to receive ROTEM
ROTEM-based coagulation monitoring
Spine surgery
|
Control Group
n=10 Participants
Patients who are randomized not to receive ROTEM
Spine surgery
|
|---|---|---|
|
Change in Platelet Count
|
-74.0 platelets/uL
Standard Deviation 66.6
|
-57.1 platelets/uL
Standard Deviation 34.2
|
SECONDARY outcome
Timeframe: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)Population: Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Rotational Thrombo-elastometry (ROTEM) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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