Factor XIII concentrate for prevention of recurrent subarachnoid hemorrhage: results of a multicenter pilot study. The FISAH Study Group.
Rebleeding after aneurysmal subarachnoid hemorrhage (SAH) has been attributed to fibrinolysis of the blood clot surrounding a rupture aneurysm. Since stability of the clot is influenced by the action of coagulation factor XIII (F XIII), high levels of F XIII might be beneficial in preventing recurrent SAH without causing the severe side effects of synthetic antifibrinolytics. We performed an open multicenter pilot study with administration of 10 x 1250 units of F XIII concentrate during the first 15 days after spontaneous SAH. Of 111 patients who were entered within 72 hours after SAH, 48 (43%) were in grades I and II, 33 (30%) were in grade III, and 30 (27%) were in grades IV and V according to Hunt & Hess. Aneurysm rupture was proved in 76 patients (68%) and aneurysm surgery was performed in 50 patients (45%). Overall mortality at four weeks was 27%. There were 11 recurrent hemorrhages in 9 patients (10%), 7 of which were fatal. Cerebral infarction occurred in 22 patients (20%) and hydrocephalus in 8 (7%). No adverse effects of therapy were noted. We conclude that F XIII therapy is a safe and promising new therapeutic approach in the management of SAH. It is currently being investigated in a large prospective, randomized, double-blind, placebo-controlled trial.
Thie
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A
Centre Hospitalier Sainte-Anne, Service de Neurochirurgie, Paris, France.
Henze
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T
D000328:Adult; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005176:Factor XIII / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D002532:Intracranial Aneurysm / Q000097:blood / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012008:Recurrence; D013345:Subarachnoid Hemorrhage / Q000097:blood / Q000517:prevention & control*
D005176:Factor XIII