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

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

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 more

Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux

Outcome measures

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 more

Outcome measures

Outcome 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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place