Trial Outcomes & Findings for Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo (NCT NCT01419977)
NCT ID: NCT01419977
Last Updated: 2015-02-16
Results Overview
Patients will have D-dimer,for samples drawn on Day 1 and Day 3
COMPLETED
PHASE2
34 participants
Day 1 and Day 3
2015-02-16
Participant Flow
Of the 34 subjects were consented, 29 are received drug and had the day 1 blood draw. 2 subjects withdrew prior to receiving study drug. In addition, 2 subjects were discharged and 1 subject received a transfusion prior to the blood draw on day 1.
Participant milestones
| Measure |
Placebo
Placebo: Normal saline solution, administered by nursing staff once daily
|
Dalteparin
Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Placebo: Normal saline solution, administered by nursing staff once daily
|
Dalteparin
n=13 Participants
Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 3Population: 9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.
Patients will have D-dimer,for samples drawn on Day 1 and Day 3
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo: Normal saline solution, administered by nursing staff once daily
|
Dalteparin
n=9 Participants
Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
|
|---|---|---|
|
Change in D-dimer
|
478.8 ng/mL
Standard Deviation 312.4
|
260.1 ng/mL
Standard Deviation 200.3
|
PRIMARY outcome
Timeframe: Baseline to day 1The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with "0" corresponding to no pain at one end and "10" indicating the worst pain at the other.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo: Normal saline solution, administered by nursing staff once daily
|
Dalteparin
n=13 Participants
Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
|
|---|---|---|
|
Change in Clinical Pain Scores
|
-0.3 units on a scale
Standard Deviation 0.5
|
-1.6 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Day 1 and Day 3Population: 9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.
Patients will have thrombin generation assay samples drawn on Day 1 and 3
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo: Normal saline solution, administered by nursing staff once daily
|
Dalteparin
n=9 Participants
Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
|
|---|---|---|
|
Change in Thrombin Generation Assay - Endogenous Thrombin Potential
|
13.4 nM
Standard Deviation 34.5
|
-45.98 nM
Standard Deviation 47.31
|
PRIMARY outcome
Timeframe: Baseline to day 3Population: 9 subjects were discharged prior to obtaining day 3 VAS score.
The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with "0" corresponding to no pain at one end and "10" indicating the worst pain at the other.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo: Normal saline solution, administered by nursing staff once daily
|
Dalteparin
n=9 Participants
Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
|
|---|---|---|
|
Change in Clinical Pain Scores
|
-0.9 units on a scale
Standard Deviation 0.2
|
-2.4 units on a scale
Standard Deviation 0.9
|
Adverse Events
Placebo
Dalteparin
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