Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT) (NCT03594045) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)
Stopped: Withdrawal of funding by sponsor
United States5 participantsStarted 2018-12-18
Plain-language summary
This research study is studying a drug as a possible treatment for heparin induced thrombocytopenia (HIT) or Heparin-induced Thrombocytopenia and Thrombosis (HITT).
The drug involved in this study is apixaban.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hospitalized patients at MGH and participating Dana Farber/Harvard Cancer Center (DF/HCC) sites.
* Patient must have a diagnosis of HIT or high clinical suspicion of HIT, with a 4 T score of ≥ 5 as calculated by the following criteria:
* Thrombocytopenia
* Platelet count fall \>50 percent and nadir ≥20,000/microL - 2 points
* Platelet count fall 30 to 50 percent or nadir 10 to 19,000/microL - 1 points
* Platelet count fall \<30 percent or nadir \<10,000/microL - 0 points
* Timing of platelet count fall
* Clear onset between days 5 and 10 or platelet count fall at ≤1 day if prior heparin exposure within the last 30 days - 2 points
* Consistent with fall at 5 to 10 days but unclear (eg, missing platelet counts), onset after day 10, or fall ≤1 day with prior heparin exposure within 30 to 100 days - 1 point
* Platelet count fall at \<4 days without recent exposure - 0 points
* Thrombosis or other sequelae
* Confirmed new thrombosis, skin necrosis, or acute systemic reaction after intravenous unfractionated heparin bolus - 2 points
* Progressive or recurrent thrombosis, non-necrotizing (erythematous) skin lesions, or suspected thrombosis that has not been proven - 1 point
* None - 0 points
* Other causes for thrombocytopenia
* None apparent - 2 points
* Possible - 1 point
* Definite - 0 points
* Prior to or immediately subsequent to enrollment, the patient must have the diagnosis confirmed by Heparin-PF4 EIA or other accepted conf…
What they're measuring
1
Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban