Novoseven during acute aortic dissection surgery

Efficacy and safety of recombinant active factor VII (NovoSeven) in acute aortic dissection surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031250287

Enrollment

Registered

2025-08-08

Start date

2025-08-08

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stanford type A acute aortic dissection Aortic dissection, Recombinant activated factor VII

Interventions

During surgery for Stanford Type A acute aortic dissection, protamine is administered after cardiopulmonary withdrawal to antagonize the effects of heparin. In addition, replenish coagulation factors

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with Stanford type A acute aortic dissection 2) Patients for whom emergency surgery is indicated after diagnosis and emergency surgery is performed within 24 hours 3) Men and women 18 years of age or older

Exclusion criteria

Exclusion criteria: 1) Patients diagnosed with congenital thrombophilia (e.g., antiphospholipid antibody syndrome, protein C deficiency, etc.) 2) Patients allergic to recombinant active factor VII 3) Pregnant women 4) Women who are breast-feeding 5) Other patients who are judged to be inappropriate as subjects by the principal investigator (subinvestigator)

Design outcomes

Primary

Measure	Time frame
Time from cardiopulmonary bypass withdrawal to the end of surgery	—

Secondary

Measure	Time frame
-Interoperative transfusion volume -Chest drainage volume after ICU admission -Transfusion volume after ICU admission -Reoperation for chest hemostasis -Ventilator management time -Serious postoperative complications (reoperation, neurological complications, extended duration on ventilator (more than 72 hours after surgery), renal failure, mediastinitis) -Life threatening thromboembolic complications in the first 4 days after study drug administration (development of acute myocardial infarction, development of acute cerebral infarction, and occurrence of acute pulmonary embolism) - Non-life-threatening thromboembolic complications and DIC in the first 4 days after study drug administration - Length of ICU stay - Length of hospitalization - Mortality at 7 days after surgery - Mortality at 30 days after surgery - ADL at discharge or 30 days after surgery - Dynamics of perioperative factor VII activity in relation to time from cardiopulmonary withdrawal to the end of surgery, blood loss, and transfusion volume - Transition of perioperative blood test findings	—

Measure

Time frame

-Interoperative transfusion volume -Chest drainage volume after ICU admission -Transfusion volume after ICU admission -Reoperation for chest hemostasis -Ventilator management time -Serious postoperative complications (reoperation, neurological complications, extended duration on ventilator (more than 72 hours after surgery), renal failure, mediastinitis) -Life threatening thromboembolic complications in the first 4 days after study drug administration (development of acute myocardial infarction, development of acute cerebral infarction, and occurrence of acute pulmonary embolism) - Non-life-threatening thromboembolic complications and DIC in the first 4 days after study drug administration - Length of ICU stay - Length of hospitalization - Mortality at 7 days after surgery - Mortality at 30 days after surgery - ADL at discharge or 30 days after surgery - Dynamics of perioperative factor VII activity in relation to time from cardiopulmonary withdrawal to the end of surgery, blood loss, and transfusion volume - Transition of perioperative blood test findings

—

Contacts

Public ContactTomomi Nakajima

University of Tsukuba Hospital

tnakajima@md.tsukuba.ac.jp+81-29-853-3097

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026