Trial Outcomes & Findings for Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT) (NCT NCT00673439)
NCT ID: NCT00673439
Last Updated: 2019-11-08
Results Overview
Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
4 weeks after INR reaches 2 or more
Results posted on
2019-11-08
Participant Flow
Participant milestones
| Measure |
Fondaparinux
daily subcutaneous injection of fondaparinux (7.5-10 mg)
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
Baseline characteristics by cohort
| Measure |
Fondaparinux
n=3 Participants
daily subcutaneous injection of fondaparinux (7.5-10 mg)
|
|---|---|
|
Age, Customized
Over 18 years of age
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after INR reaches 2 or moreClinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
Outcome measures
| Measure |
Fondaparinux
n=3 Participants
daily subcutaneous injection of fondaparinux (7.5-10 mg)
|
|---|---|
|
Number of Participants Showing Clinically Significant Bleeding
|
0 participants
|
SECONDARY outcome
Timeframe: 4 weeks after INR reaches 2 or moreOutcome measures
| Measure |
Fondaparinux
n=3 Participants
daily subcutaneous injection of fondaparinux (7.5-10 mg)
|
|---|---|
|
the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
|
0 Participants
|
Adverse Events
Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
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
Goetz H Kloecker, MD, MSPH
James Graham Brown Cancer Center
Phone: 502/562-4358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place