Patients receiving anti-factor Xa inhibitors who experience major bleeding Anticoagulants Factor Xa Inhibitors Hemorrhage Prothrombin complex concentrates
Conditions
Interventions
Patients with major bleeding or those in a perioperative setting requiring prothrombin complex concentrate (PCC).
Treatment
PCC group
Sponsors
Division of Hematology, Department of Medicine, Phramongkutklao Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with major bleeding based on ISTH criteria 2. Patients requiring emergency surgery or invasive procedures with a high risk of major bleeding, as assessed by a surgeon and an internist. 3. Age over 18 years. 4. Patients who received prothrombin complex concentrate (PCC) following the diagnosis of major bleeding or for the prevention of bleeding related to surgery. 5. Patients who received direct factor Xa inhibitors within 48 hours prior to treatment in patients with normal renal function, or within 72 hours in those with impaired renal function.
Exclusion criteria
Exclusion criteria: 1. Patients without an electronic hospital medical record. 2. Patients with a history of receiving vitamin K, prothrombin complex concentrate (PCC), blood components (including whole blood and plasma fraction), or reversal agents for major bleeding (e.g., andexanet alfa for direct factor Xa inhibitors) within the past 7 days. 3. Patients with a history of receiving parenteral anticoagulants such as unfractionated heparin or low molecular weight heparin within the past 24 hours. 4. Pregnant or breastfeeding women. 5. Patients diagnosed with severe sepsis or septic shock. 6. Patients with a history of thromboembolic events within 2 weeks prior to PCC administration, including myocardial infarction, disseminated intravascular coagulation (DIC), cerebrovascular accident (CVA), transient ischemic attack (TIA), or severe peripheral arterial disease. 7. Patients with intracranial hemorrhage presenting with a Glasgow Coma Scale (GCS) score less than 7, or with a hematoma volume greater than 60 mL as measured by brain computed tomography (CT) scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostatic effectiveness Within 24 hr after PCC administration Clinical evaluation criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction Within 24 hr after PCC administration Clinical evaluation,Mortality At 30 days Clinical evaluation,Thrombosis Within 1 year after PCC administration CT pulmonary angiography (CTPA) or compression ultrasonography | — |
Countries
Thailand
Contacts
Public ContactTanapun Thamgrang
Division of Hematology, Department of Medicine, Phramongkutklao Hospital
Outcome results
None listed