A study to confirm that andexanet alfa helps to stop severe/ life threatening bleeding in patients, taking a type of anticoagulants called Factor Xa inhibitors.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

1) Either the patient or his or her medical proxy has been adequately informed of the nature and risks of the study and has given written informed consent prior to Screening;
2) The patient must be at least 18 years old at the time of Screening;
3) The patient must have an acute overt major bleeding episode requiring urgent reversal of anticoagulation; Acute major bleeding requiring urgent reversal of anticoagulation is defined by at least ONE of the following:
- Acute overt bleeding that is potentially life-threatening, e.g., with signs or symptoms of haemodynamic compromise, such as severe hypotension, poor skin perfusion, mental confusion, low urine output that cannot be otherwise explained;
- Acute overt bleeding associated with a fall in haemoglobin level by = 2 g/dL, OR a Hb = 8 g/dL if no baseline Hb is available OR, in the opinion of the investigator that the patient’s haemoglobin will fall to = 8 g/dL with resuscitation;
- Acute symptomatic bleeding in a critical area or organ, such as, intra-spinal, retroperitoneal, intra-articular or pericardial, intracranial, or intramuscular with compartment syndrome.
4) The patient, for whom the bleeding is intracranial must have undergone a head CT or MRI scan demonstrating the intracranial bleeding. Note: Patients with bleeding at non-intracranial locations do not require a head CT or MRI;
5) Patient received or believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin (dose of enoxaparin =1mg/kg/d).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

Exclusion Criteria

1) The patient is scheduled to undergo surgery in less than 12 hours with the exception of minimally invasive surgery/procedures (e.g., endoscopy, bronchoscopy, central lines, Burr holes);
2) A patient with ICH has any of the following:
- Glasgow coma score < 7
- Estimated intracerebral haematoma volume >60 cc as assessed by the CT or MRI.
3) The patient has an expected survival of less than 1 month;
4) The patient has a recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows: myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris hospitalization, or severe peripheral vascular disease within 2 weeks prior to Screening;
5) The patient has severe sepsis or septic shock at the time of Screening;
6) The patient is pregnant or a lactating female;
7) The patient has received any of the following drugs or blood products within 7 days or Screening:
• Vitamin K antagonist (VKA) (e.g., warfarin);
• Dabigatran;
• Prothrombin Complex Concentrate products (PCC, e.g., Kcentra®) or recombinant factor VIIa (rfVIIa) (e.g., NovoSeven®);
• Whole blood, plasma fractions
Note: Administration of platelets or packed red blood cells (PRBCs) is not an exclusion criterion;
8) The patient was treated with an investigational drug <30 days prior to Screening.
Planned administration of PCC, fresh frozen plasma (FFP), or rfVIIa from Screening until within 12 hours after the end of the andexanet infusion;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 10/17/2023

A study to confirm that andexanet alfa helps to stop severe/ life threatening bleeding in patients, taking a type of anticoagulants called Factor Xa inhibitors.

Recruitment & Eligibility

Study & Design

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