Excretion of Rivaroxaban in Human Breast Milk

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for women within 6 weeks after giving birth who need rivaroxaban, a blood thinner, to prevent or treat blood clots. It studies how much of the drug passes into breast milk.

Életkor

Over 18 years old at the expected date of delivery.

Nem

Women only.

A betegség stádiuma

Within 6 weeks after delivery and medically stable, with no worry about ongoing blood loss. Women need a reason for a preventive dose of the blood thinner, such as a BMI of 40 or more before pregnancy or a past blood clot. Two or more of these also count: BMI 30-39 before pregnancy, being unable to move around, pregnancy problems, caesarean delivery or removal of the womb. Women can also join if their doctors say they need a full treatment dose of the blood thinner.

A részvétel fő kizáró okai

• Being pregnant.
• A new deep vein clot or lung clot found after the birth.
• Poor kidney or liver function (creatinine clearance < 30 mL/min, or liver tests above lab normal).
• Allergy to rivaroxaban or active bleeding.
• Breastfeeding a baby who is in neonatal intensive care, was born before 37 weeks or weighed less than 2600g.

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

A vizsgálat 2 csoportja

• Prophylactic rivaroxabanMár használt kezelés, összehasonlításként

  Patients will receive 10 mg daily of rivaroxaban starting by the first postpartum day. The medication will be ordered by their postpartum physician team through the inpatient pharmacy and dispensed by their inpatient nursing team, as per standard of care. The decision for dose 10 mg vs 20 mg of rivaroxaban is based on inclusion criteria and patient's physician team's recommendation for prophylactic (10 mg) vs. therapeutic (20 mg) dosing.

  Kezelés: Rivaroxaban 10 MG Oral Tablet

• Therapeutic or Intermediate dose rivaroxabanMár használt kezelés, összehasonlításként

  Patients will receive 20 mg daily of rivaroxaban starting by the first postpartum day. The medication will be ordered by their postpartum physician team through the inpatient pharmacy and dispensed by their inpatient nursing team, as per standard of care. The decision for 10 mg vs 20 mg of rivaroxaban is based on inclusion criteria and patient's physician team's recommendation for prophylactic (10 mg) vs. therapeutic (20 mg) dosing.

  Kezelés: Rivaroxaban 20 MG Oral Tablet