brain tumors or cerebral arteriovenous malformations requiring craniotomy Coagulation factor XIII activity, Intracranial disease, Craniotomy
Conditions
Interventions
Treatment Protocol
Factor XIII Supplementation
If the coagulation factor XIII activity is less than 60% on the day after surgery, Inject 1-5V of Fibrogamin P intravenously for 5 days from the day afte
Coagulation factor FXIII concentrates
Sponsors
Uozumi Yoichi
Sasayama Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 disease, the consent of their legal guardian is required.) 2. Patients undergoing craniotomy for brain tumors or cerebral arteriovenous malformations 3. Patients whose preoperative coagulation factor XIII activity was within the normal range (70-140%) and whose coagulation factor XIII activity decreased to less than 60% the day after craniotomy
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. Low birth weight infants and newborns at the time of obtaining consent 3. Patients who are participating in other interventional studies and using the test drugs in those studies 4. Patients with congenital coagulation disorders other than congenital coagulation factor XIII deficiency 5. Other patients deemed unsuitable by the physician in charge of this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative intracranial hemorrhage requiring reoperation within 7 days after craniotomy | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation 1. Incidence of symptomatic postoperative intracranial hemorrhage within 7 days after craniotomy 2. Incidence of postoperative CSF leakage requiring repair surgery 3. Incidence of delayed wound healing 4. Changes in perioperative F XIII activity and plasma fibrinogen levels 5. Coagulation factor XIII activity and plasma fibrinogen levels 3 months after surgery Safty evaluation 1. Occurence of protocol treatment-related complications during the observation period | — |
Contacts
Public ContactYoichi Uozumi
Kobe University Hospital
Outcome results
None listed