An exploratory study to investigate the effect of preoperative correction on tumor resection in patients with decreased coagulation factor XIII activity.

An exploratory study to investigate the effect of preoperative correction on the course of coagulation factor XIII activity after tumor resection in patients with decreased coagulation factor XIII activity.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051240079

Enrollment

Registered

2024-06-28

Start date

2025-09-30

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

Brain tumors with coagulation factor XIII activity decreased to less than 60% Coagulation factor XIII activity, Brain tumor

Interventions

1) When coagulation factor XIII activity is less than 60% and plasma fibrinogen is 150 mg/dL or more in preoperative blood test: Administer 1-5V of Fibrogamin P intravenously for 5 days starting the

D064826

Blood products transfusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed brain tumor patients undergoing tumor removal through craniotomy 2. Patients whose coagulation factor XIII activity decreased to less than 60% in preoperative blood tests 3. Patients who have given their own free written consent to participate in this study (In the case of patients under 18 years of age, the consent of the patient and their legal guardian is required, and in the case of patients with impaired consciousness due to a brain tumor, the consent of their legal guardian is required.)

Exclusion criteria

Exclusion criteria: 1. Patients who are known to be hypersensitive to therapeutic drugs for decreased coagulation factor XIII activity and low plasma fibrinogen levels 2. Patients with contraindications to treatment for decreased coagulation factor XIII activity and low plasma fibrinogen levels 3. Low birth weight infants and newborns at the time of consent (safety not established) 4. Patients participating in other intervention trials and using the study drug 5. Reoperation cases 6. Patients with congenital coagulation disorders excluding congenital coagulation factor XIII deficiency 7. Other patients deemed unsuitable by the physician in charge of this clinical study

Design outcomes

Primary

Measure	Time frame
Changes in coagulation factor XIII activity for 14 days after surgery	—

Secondary

Measure	Time frame
1. Symptomatic postoperative bleeding that occurs within 7 days after surgery (diagnosed based on postoperative images and clinical symptoms) 2. Asymptomatic postoperative bleeding that occurs within 7 days after surgery (diagnosed by postoperative imaging) 3. Occurence of postoperative cerebrospinal fluid leakage 4. Occurence of delayed wound healing after surgery 5. Changes in plasma fibrinogen level for 14 days after surgery 6. Coagulation factor XIII activity and plasma fibrinogen levels 6 months after surgery 7. Occurence of protocol treatment-related complications	—

Measure

Time frame

1. Symptomatic postoperative bleeding that occurs within 7 days after surgery (diagnosed based on postoperative images and clinical symptoms) 2. Asymptomatic postoperative bleeding that occurs within 7 days after surgery (diagnosed by postoperative imaging) 3. Occurence of postoperative cerebrospinal fluid leakage 4. Occurence of delayed wound healing after surgery 5. Changes in plasma fibrinogen level for 14 days after surgery 6. Coagulation factor XIII activity and plasma fibrinogen levels 6 months after surgery 7. Occurence of protocol treatment-related complications

—

Contacts

Public ContactYoichi Uozumi

Kobe University Hospital

uozumi@med.kobe-u.ac.jp+81-78-382-5966

Outcome results

None listed

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