Trial Outcomes & Findings for IV Ketorolac on Platelet Function Post-Cesarean Delivery (NCT NCT03805607)
NCT ID: NCT03805607
Last Updated: 2026-05-29
Results Overview
Platelet Aggregometry measures the percent change in light transmission as a marker of platelet aggregation. The outcome is determined by the percentage of inhibition of platelet aggregation comparing the pre-drug values and the post-drug values. Higher number of inhibition indicates greater inhibition, meaning greater drug effect on platelet function.
COMPLETED
PHASE4
40 participants
15 minutes after dosing of placebo or ketorolac
2026-05-29
Participant Flow
Participant milestones
| Measure |
Placebo
1 ml of normal saline
Placebo: Normal Saline
|
Ketorolac
30 mg of ketorolac in 1 ml
Ketorolac Tromethamine 30 MG/ML: Ketorolac 30 mg
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Placebo
1 ml of normal saline
Placebo: Normal Saline
|
Ketorolac
30 mg of ketorolac in 1 ml
Ketorolac Tromethamine 30 MG/ML: Ketorolac 30 mg
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Case delayed
|
0
|
1
|
|
Overall Study
Sample clotted
|
3
|
1
|
|
Overall Study
Excessive intraoperative bleeding
|
1
|
0
|
Baseline Characteristics
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
1 ml of normal saline
|
Ketorolac
n=17 Participants
30 mg of ketorolac in 1 ml
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 Years
STANDARD_DEVIATION 3.2 • n=51 Participants
|
34.9 Years
STANDARD_DEVIATION 4.2 • n=14 Participants
|
34.7 Years
STANDARD_DEVIATION 3.7 • n=65 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=51 Participants
|
17 Participants
n=14 Participants
|
31 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
5 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
5 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=51 Participants
|
10 Participants
n=14 Participants
|
21 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=51 Participants
|
14 Participants
n=14 Participants
|
27 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Weight
|
86.3 Kilograms
STANDARD_DEVIATION 15.7 • n=51 Participants
|
85.2 Kilograms
STANDARD_DEVIATION 19.0 • n=14 Participants
|
85.7 Kilograms
STANDARD_DEVIATION 17.3 • n=65 Participants
|
|
Body Mass Index
|
31.5 kilograms/meter*2
STANDARD_DEVIATION 5.6 • n=51 Participants
|
32.4 kilograms/meter*2
STANDARD_DEVIATION 6.5 • n=14 Participants
|
32.0 kilograms/meter*2
STANDARD_DEVIATION 6.0 • n=65 Participants
|
|
Nulliparity
|
1 count of subjects
n=51 Participants
|
2 count of subjects
n=14 Participants
|
3 count of subjects
n=65 Participants
|
|
Gestational age
|
39 Weeks
n=51 Participants
|
39.1 Weeks
n=14 Participants
|
39.1 Weeks
n=65 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after dosing of placebo or ketorolacPlatelet Aggregometry measures the percent change in light transmission as a marker of platelet aggregation. The outcome is determined by the percentage of inhibition of platelet aggregation comparing the pre-drug values and the post-drug values. Higher number of inhibition indicates greater inhibition, meaning greater drug effect on platelet function.
Outcome measures
| Measure |
Placebo
n=14 Participants
1 ml of normal saline
Placebo: Normal Saline
|
Ketorolac
n=17 Participants
30 mg of ketorolac in 1 ml
Ketorolac Tromethamine 30 MG/ML: Ketorolac 30 mg
|
|---|---|---|
|
Platelet Aggregometry
|
65.4 Percentage of light transmission
Standard Deviation 2.7
|
59.1 Percentage of light transmission
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 15 minutes after dosing of placebo or ketorolacReaction time (R) represents the time in minutes from the start of the test (sample insertion) until the initial fibrin formation defined as a 2mm amplitude change in deviation of the probe. This represents the initiation phase of coagulation.
Outcome measures
| Measure |
Placebo
n=14 Participants
1 ml of normal saline
Placebo: Normal Saline
|
Ketorolac
n=17 Participants
30 mg of ketorolac in 1 ml
Ketorolac Tromethamine 30 MG/ML: Ketorolac 30 mg
|
|---|---|---|
|
Thromboelastogram Parameters Including Reaction Time (R)
|
4.5 minutes
Standard Deviation 0.96
|
5.3 minutes
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 15 minutes after dosing of placebo or ketorolacThe TEG alpha angle represents the speed of clot formation after the initiation phase. It measures the slope of the TEG tracing between the R-value and K-value (between 2mm and 20mm amplitude), reflecting the "thrombin burst" and acceleration of clot strengthening.
Outcome measures
| Measure |
Placebo
n=14 Participants
1 ml of normal saline
Placebo: Normal Saline
|
Ketorolac
n=17 Participants
30 mg of ketorolac in 1 ml
Ketorolac Tromethamine 30 MG/ML: Ketorolac 30 mg
|
|---|---|---|
|
Thromboelastogram Parameters Including Angle (Alpha)
|
76.5 Degrees
Standard Deviation 1.2
|
77.1 Degrees
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 15 minutes after dosing of placebo or ketorolacK-time measures the speed of clot development, representing the time taken for the clot to increase in strength from initial fibrin formation (end of R-time) to a fixed 20 mm amplitude. It acts as an amplification phase indicator, primarily dependent on fibrinogen levels and platelet function.
Outcome measures
| Measure |
Placebo
n=14 Participants
1 ml of normal saline
Placebo: Normal Saline
|
Ketorolac
n=17 Participants
30 mg of ketorolac in 1 ml
Ketorolac Tromethamine 30 MG/ML: Ketorolac 30 mg
|
|---|---|---|
|
Thromboelastogram Parameters Including Kinetics (K-time)
|
0.936 minutes
Standard Deviation 0.12
|
0.929 minutes
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 15 minutes after dosing of placebo or ketorolacMaximum Amplitude (MA) measures the maximum strength or firmness of a fibrin clot, representing the widest point of the TEG tracing.
Outcome measures
| Measure |
Placebo
n=14 Participants
1 ml of normal saline
Placebo: Normal Saline
|
Ketorolac
n=17 Participants
30 mg of ketorolac in 1 ml
Ketorolac Tromethamine 30 MG/ML: Ketorolac 30 mg
|
|---|---|---|
|
Thromboelastogram Parameters Including Maximum Amplitude (MA)
|
66.7 millimeters
Standard Deviation 1.8
|
64.0 millimeters
Standard Deviation 3.6
|
Adverse Events
Placebo
Ketorolac
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauren Peter, Research Compliance
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place