Trial Outcomes & Findings for In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography. (NCT NCT00788255)
NCT ID: NCT00788255
Last Updated: 2016-11-28
Results Overview
thromboelastographic indices - reaction time (normal range, 5-10 min)
Recruitment status
COMPLETED
Target enrollment
25 participants
Primary outcome timeframe
6 months
Results posted on
2016-11-28
Participant Flow
Participant milestones
| Measure |
All Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
Oxytocin Infusion 1: 22.5 μU/mL
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25
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Overall Study
Oxytocin Infusion 2: 30.1μU/mL
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25
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Overall Study
Oxytocin Infusion 3: 32.9μU/mL
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25
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Overall Study
Oxytocin: 0 μU/mL
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25
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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25 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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25 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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25 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsthromboelastographic indices - reaction time (normal range, 5-10 min)
Outcome measures
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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r Time
Exogenous Oxytocin 22.5
|
5.6 minutes
Standard Deviation 1.4
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r Time
Exogenous Oxytocin 30.1
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4.2 minutes
Standard Deviation 1.3
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r Time
Exogenous Oxytocin 32.9
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3.9 minutes
Standard Deviation 1.3
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r Time
Exogenous oxytocin 0
|
6 minutes
Standard Deviation 1.5
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PRIMARY outcome
Timeframe: 6 monthsthromboelastographic indices - clot formation time (normal range, 1-3 min)
Outcome measures
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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|---|---|
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k Time
Exogenous Oxytocin 22.5
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1.6 minutes
Standard Deviation 0.4
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k Time
Exogenous Oxytocin 30.1
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1.5 minutes
Standard Deviation 0.7
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k Time
Exogenous Oxytocin 32.9
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1.4 minutes
Standard Deviation 0.4
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k Time
Exogenous Oxytocin 0
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1.7 minutes
Standard Deviation 0.4
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PRIMARY outcome
Timeframe: 6 monthsthromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)
Outcome measures
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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|---|---|
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Alpha Angle
Exogenous Oxytocin 22.5
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67.4 degrees
Standard Deviation 4.2
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Alpha Angle
Exogenous Oxytocin 30.1
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67.7 degrees
Standard Deviation 3.7
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Alpha Angle
Exogenous Oxytocin 32.9
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69.4 degrees
Standard Deviation 4.2
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Alpha Angle
Exogeneous oxytocin 0
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66.2 degrees
Standard Deviation 4.4
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PRIMARY outcome
Timeframe: 6 monthsthromboelastographic indices - maximum amplitude (normal range, 50-70 mm)
Outcome measures
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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|---|---|
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MA
Exogenous Oxytocin 22.5
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69.8 mm
Standard Deviation 4.3
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MA
Exogenous Oxytocin 30.1
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67.2 mm
Standard Deviation 3.7
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MA
Exogenous Oxytocin 32.9
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69.0 mm
Standard Deviation 4.2
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MA
Exogeneous Oxytocin 0
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67.2 mm
Standard Deviation 3.9
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PRIMARY outcome
Timeframe: 6 monthsthromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)
Outcome measures
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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|---|---|
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MRTG
Exogenous Oxytocin 22.5
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13.5 mm/min
Standard Deviation 2.7
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MRTG
Exogenous Oxytocin 30.1
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14.9 mm/min
Standard Deviation 3.7
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MRTG
Exogenous Oxytocin 32.9
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14.3 mm/min
Standard Deviation 2.8
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MRTG
Exogeneous Oxytocin 0
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12.8 mm/min
Standard Deviation 2.5
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PRIMARY outcome
Timeframe: 6 monthsthromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)
Outcome measures
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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|---|---|
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Tmax
Exogenous Oxytocin 22.5
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6.9 minutes
Standard Deviation 1.6
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Tmax
Exogenous Oxytocin 30.1
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5.4 minutes
Standard Deviation 1.9
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Tmax
Exogenous Oxytocin 32.9
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5.0 minutes
Standard Deviation 1.5
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Tmax
Exogeneous Oxytocin 0
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7.5 minutes
Standard Deviation 1.7
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PRIMARY outcome
Timeframe: 6 monthsthromboelastographic indices - total thrombus generation (normal range, 584-796 mm)
Outcome measures
| Measure |
All Participants
n=25 Participants
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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|---|---|
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TTG
Exogenous Oxytocin 22.5
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845.9 mm
Standard Deviation 53.9
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TTG
Exogenous Oxytocin 30.1
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820 mm
Standard Deviation 45.9
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TTG
Exogenous Oxytocin 32.9
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839.7 mm
Standard Deviation 51.8
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TTG
Exogeneous Oxytocin 0
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819.4 mm
Standard Deviation 48.9
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Adverse Events
22.5 μU/mL Exogenous Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30.1 μU/mL Exogenous Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
32.9 μU/mL Exogenous Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0 μU/mL Exogenous Oxytocin
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
Dr. Alexander Butwick
Stanford University School of Medicine
Phone: (650) 736-8513
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place