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

JRCT ID: jRCTs051240079

Registered date:28/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Brain tumors with coagulation factor XIII activity decreased to less than 60%
• Date of first enrollment: 28/06/2024
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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 day before surgery. However, when the coagulation factor XIII activity on the 3rd day of administration is 100% or higher, administration should be terminated after 3 days.
2) When coagulation factor XIII activity is less than 60% and plasma fibrinogen is less than 150 mg/dL in preoperative blood test:
In addition to treatment 1), administer fresh frozen plasma until the fibrinogen concentration reaches 150 mg/dL or higher by the day before surgery.

Outcome(s)

• Primary Outcome: Changes in coagulation factor XIII activity for 14 days after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: > 4weeks old
• Age maximum: Not applicable
• Gender: Both

Include 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.)

Exclude 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

Related Information

• Primary Sponsor: Uozumi Yoichi
• Secondary Sponsor: Sasayama Takashi