Four-factor prothrombin complex concentrates outcomes in surgery and major bleed

Not Applicable

• Conditions: Blood loss, surgical; Surgery

• Registration Number: ISRCTN13973041
• Lead Sponsor: Takeda (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-29
• Last Update Posted: 19 February 2024
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified