Prothromplex (prothrombin complex) / Takeda - LARVOL DELTA

A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery (clinicaltrials.gov) - P3 | N=328 | Recruiting | Sponsor: Takeda | Trial completion date: Nov 2025 ➔ Apr 2028 | Trial primary completion date: Nov 2025 ➔ Apr 2028

Surgery • Trial completion date • Trial primary completion date • Hematological Disorders

A phase 3 trial of TAK-330 (4-factor prothrombin complex concentrate [4F-PCC]) vs standard-of-care 4F-PCCs for FXa inhibitor-induced anticoagulation reversal before urgent surgery/invasive procedure (ISTH 2024) - P3 | "It aims to recruit 328 patients (≥18 years old) currently receiving an oral FXa inhibitor (rivaroxaban, apixaban, or edoxaban) who require urgent surgery/invasive procedures with a high-risk of intraoperative bleeding within 15 hours of their last FXa inhibitor dose. Not applicable. Conclusion(s) : Results from this study will provide efficacy and safety data on TAK-330 versus standard-of-care 4F-PCCs for the reversal of direct oral FXa inhibitor-induced anticoagulation in patients requiring urgent surgery/invasive procedures."

P3 data • Surgery • Critical care

Safety assessment of Prothromplex®, a 4-factor prothrombin complex concentrate, focused on heparin-related adverse events (ISTH 2024) - "Based on a cumulative number of 2,937,615,196 IU of Prothromplex®, no cases of HIT were reported. Overall reporting rates for other search criteria were: hypersensitivity, 13.3 events per billion IU (16 cases); lack of effect, 3.1 events per billion IU (9 cases); and thrombotic events, 14.3 events per billion IU (41 cases). The most commonly reported events in these categories were ischemic stroke (n=13), deep vein thrombosis (n=11), bronchospasm (n=6), erythema (n=5) and drug ineffective (n=5)."

Adverse events • Clinical • Cardiovascular • Dermatology • Hematological Disorders • Immunology • Ischemic stroke • Thrombocytopenia • Thrombosis • Venous Thromboembolism

A RETROSPECTIVE CHART REVIEW TO EVALUATE 4-FACTOR PROTHROMBIN COMPLEX CONCENTRATES FOR THE REVERSAL OF FACTOR XA INHIBITORS BEFORE SURGERY OR MAJOR BLEEDING (EAHAD 2023) - "The primary objective is to evaluate the hemostatic effectiveness of a 4F-PCC (Prothromplex Total® [PKT]) with other 4F-PCCs...Data will be collected from hospital charts of patients ≥ 18 years old receiving an oral FXa inhibitor (rivaroxaban, apixaban, edoxaban) at the time of surgery/major bleed who present between January 1, 2019 and July 15, 2022... This study will provide evidence for the effectiveness and safety of 4F-PCCs in a large real-world population requiring oral FXa inhibitor reversal for surgery or major bleeding. This study is expected to fulfil an important evidence gap in oral FXa inhibitor reversal."

Retrospective data • Review • Surgery • Cardiovascular

A Trial of PROTHROMPLEX TOTAL for Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation (clinicaltrials.gov) - P3 | N=328 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders

A Trial of PROTHROMPLEX TOTAL for Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation (clinicaltrials.gov) - P3 | N=328 | Not yet recruiting | Sponsor: Takeda | Initiation date: May 2022 ➔ Aug 2022

Trial initiation date • Hematological Disorders

A Trial of PROTHROMPLEX TOTAL for Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation (clinicaltrials.gov) - P3; N=328; Not yet recruiting; Sponsor: Takeda

Clinical • New P3 trial • Hematological Disorders

[VIRTUAL] Heparinase treatment to remove the inhibitory heparin effect on the thrombin generation assay (GTH 2021) - "Methods The heparin-containing 4F-PCC sample (Prothromplex Total, Baxter) was mixed with Heparinase I (Sigma) and incubated for 5 min at room temperature...Conclusion Enzymatic breakdown of heparin by heparinase I efficiently removed the inhibitory effect of heparin observed during the TGA of 4F-PCCs. Heparinase I treatment can easily introduced in existing TGA test procedures and will increase the significance of data generated with TGA."

[VIRTUAL] Efficacy and Safety of Prothrombin Complex Concentrate in Obstetric Hemorrhage (ISTH 2020) - "It was determined that the use of Prothromplex 600 IU decreased the number of patients with transfusion FFP 12-15 ml/kg by 27.8% and increased the number of patients without transfusion by 25.9%, compared with patients without use of Prothromplex 600 IU. The use of PCC safety and efficacy reduce use of FFP during PPH."

Clinical • Anesthesia • Gynecology • Hematological Disorders • Hypertension • Mood Disorders • Postpartum Hemorrhage • Pulmonary Arterial Hypertension • Respiratory Diseases • F2

Reversal of Warfarin Using Low Dose Prothromplex Total, a 4-factor Prothrombin Complex and Its Implications on Fix-dosing Regimens (ISTH 2019) - "Our study supports the use of 4F-PCC at 20-25iu/kg and provides guidance for consideration of a fixed dose regimen."