Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation

Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation - Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018998

Enrollment

Registered

2015-10-01

Start date

2015-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

patients with end-stage heart failure who underwent left ventricular assist device support

Interventions

control group:LVAD implantation treatment group: LVAD implantation with postoperative administraion of concentrates of blood coagulation factor XIII (Fibrogammin&amp

reg

P 240U/V 5V) at the time of admission of intensive care unit and 24 and 48 hours after operation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: the patients with end-stage heart failure due to dilated cardiomyopathy, ischemic cardiomyopathy and other cardiomyopathy who is planned to undergo left ventricular assit device implantation

Exclusion criteria

Exclusion criteria: the patients with sensitivity to concentrate of blood coagulaton factor XIII the patients with sensitivity to other blood products

Design outcomes

Primary

Measure	Time frame
bleeding complication in postoperative periods including brain hemorrage, gastrointestinal hemorrage and wound bleeding requring blood transfusion	—

Secondary

Measure	Time frame
blood transfusion volume in postoperative period amount of bleeding in postoperative period perioperative changes of blood coagulation factors	—

Countries

Japan

Contacts

Public ContactKeitaro Domae

Graduate school of Medicine, Osaka University Department of Cardiovascular Surgery

k-domae@surg1.med.osaka-u.ac.jp06-6879-3154

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026