Blood loss, surgical Surgery
Conditions
Interventions
Data will be collected from the patients medical records during the pre-treatment period (prior to receiving the first 4F-PCC dose) and post-treatment period (30-90 days after the first 4F-PCC dose).
Sponsors
Takeda (United States)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Surgery indication: 1. Patient was >18 years of age at the time of surgery/invasive procedure 2. Patient was on treatment with an oral FXa inhibitor (rivaroxaban, apixaban, edoxaban) at time of surgery/invasive procedure 3. Patient admitted for a high-bleeding risk surgery (e.g., intra-abdominal surgery [e.g., bowel or visceral organ resection]), intra-thoracic surgery (e.g., lung resection), major orthopedic surgery (e.g., hip/knee replacement], arterial revascularization (e.g., abdominal aortic aneurysm repair, vascular bypass), urologic surgery (e.g., prostatectomy, bladder tumor resection), any other surgery lasting = 1 hour, or major invasive procedure with high bleeding risk (e.g., colonic polyp resection, biopsy of kidney or prostate) 4. Patient received Takeda PROTHROMPLEX TOTAL or other 4F-PCC (e.g., Beriplex/Kcentra, Octaplex, Cofact, Uman Complex, Kanokad, Kedcom) reversal infusion during surgery or an invasive procedure as their first reversal agent type to control intra-operative bleeding in patients admitted for surgery/invasive procedure Major bleed indication: 1. Patient was >18 years of age at time of admission for an acute major bleed 2. Patient was on treatment with an oral FXa inhibitor (rivaroxaban, apixaban, edoxaban) at the time of major bleed 3. Patient received a 4F-PCC reversal infusion (e.g., Beriplex/Kcentra, Octaplex, PROTHROMPLEX TOTAL, Cofact, Uman Complex, Kanokad, Kedcom) for a major bleed as their first on-demand reversal agent type 4. Acute major bleeding, defined as bleeding that is potentially life-threatening, that requires an emergent surgery or invasive procedure, or requires transfusion of =1 units of PRBCs or is associated with a decrease in Hg of >2.0 g/dL, or bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial. Acute bleeding associated with a Hg level of =8 g/dL if no baseline Hg is available is also considered major.
Exclusion criteria
Exclusion criteria: Surgery indication: Cohort 1: Real-world patients undergoing reversal with 4F-PCC 1. Patient presented with an acute bleed that required on-demand therapy with 4F-PCC 2. Patient underwent a low-bleeding risk surgery/invasive procedure (gastrointestinal endoscopy [with or without biopsy], cardiac catheterization [with or without percutaneous coronary intervention], permanent pacemaker or internal defibrillator insertion, dental surgery or other dental procedure, dermatologic surgery or other dermatologic procedure, cataract removal or other ophthalmologic procedure, any other surgery or procedure lasting < 1 hour) 3. Participation in a clinical study involving an investigational product or device within 30 days prior to or after initiation of 4F-PCC reversal Bleeding indication: Cohort 2: Real-world patients undergoing on-demand reversal with 4F-PCC for major bleeding 1. Patient with acquired/congenital hemostatic disorders, e.g., hemophilia A and B, platelet function disorder, fibrinogen deficiency, Von Willebrand disease, coagulation factor deficiency, acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C (1)), confirmed or suspected sepsis 2. Patient with minor bleeding (e.g., epistaxis, hematuria) 3. Peri-operative reversal with 4F-PCC to control intra-operative bleeding in patients admitted for surgery/invasive procedure 4. Participation in a clinical study within 30 days post initiation of 4F-PCC on-demand reversal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgery indication: 1. Intra-operative hemostatic effectiveness will be regarded as effective or ineffective based on a review of intraoperative documentation 2. Post-operative hemostatic effectiveness within 24 hours after index 4F-PCC infusion will be regarded as effective or ineffective based on a review of postoperative documentation. Absence of post-operative bleeding or oozing will be classified as effective hemostasis. Bleeding indication: Hemostatic effectiveness will be measured using the International Society on Thrombosis and Haemostasis (ISTH) criteria, Modified Sarode Criteria, Glasgow Coma Score or NIH Stroke Scale (NIHSS) score within 1 hour, 6 hours, and 24 hours of 4F-PCC infusion. Change in clinical status over time will be measured using: 1. American College of Surgeons Advanced Trauma Life Support (ATLS) classification of blood loss based on the following signs and symptoms within 1, 6, and 24 hours of index 4F-PCC infusion 2. Clinical opinion based on progress notes for evidence of a change in: a) clinical status and b) amount of bleeding within 1, 6, and 24 hours of index 4F-PCC infusion as worse, no-change (stable), better, or undocumented will be captured for every type of bleed and recurrence of bleeding at the same site as the initial bleed prior to discharge All outcome measures are collected retrospectively from medical charts | — |
Secondary
| Measure | Time frame |
|---|---|
| As this is an exploratory study, there are no key secondary outcomes that are powered to address any predefined hypothesis. Secondary outcomes data is abstracted from patient chart data. The secondary objectives are as follows: Surgery indication: 1. Baseline characteristics, including FXa inhibitor type, dose, and time of last FXa inhibitor dose prior to procedure, anti-FXa level and assay type (calibrated) indication for anticoagulation, concurrent antiplatelet, anticoagulant, prothrombotic and fibrinolytic therapy, and comorbidities of patients who require 4F-PCC reversal therapy of FXa inhibitor anticoagulation during surgical/interventional procedures. 2. Clinical practice patterns, including procedure type, reversal agent administration characteristics (e.g., administration method [IV push, bolus, infusion], dose, concentration, time between reversal agent infusion and initiation of surgery, use of additional doses of reversal agents, and time of administration), use of other interventions for control of hemostasis, i.e., transfusions (e.g., PRBC, FFP transfusions), other pharmacological agents and invasive procedures, reinitiation of anticoagulant therapy within 30-days of index 4F-PCC infusion (type of anticoagulant, dose, time of re-initiation), and method used to monitor anticoagulant therapy (no monitoring, PT, TT, aPTT, anti-FXa assay, ecarin clotting time [ECT], thrombin generation assay [TGA]). Bleeding indication: 1. Baseline characteristics, including FXa inhibitor type, dose, and time of last FXa inhibitor dose, Anti-FXa level prior to 4F-PCC infusion, indication for anticoagulation, concurrent antiplatelet, anticoagulant, prothrombotic and fibrinolytic therapy, Glasgow Comma Score, intracerebral hemorrhage (ICH) hematoma volume, and comorbidities of patients who require 4F-PCC reversal therapy of FXa inhibitor anticoagulation for acute major bleeds 2. Clinical practice patterns, including type and location of bleed, reversal agent administrati | — |
Countries
Austria, Belgium, England, Germany, Greece, Netherlands, Poland, Spain, United Kingdom
Contacts
Public ContactNidhi Guatam
Outcome results
None listed