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Active clinical trials for "Factor XIII Deficiency"

Results 1-10 of 10

Clinical Trial of Factor XIII (FXIII) Concentrate

HemophiliaFactor XIII Deficiency

Congenital deficiency of Factor XIII is a rare but potentially life threatening disorder. It is inherited in an autosomal recessive fashion. Infusion of Factor XIII has proved to be useful for prevention and treatment of bleeding episodes, especially of spontaneous intracranial bleedings. In this study, Fibrogammin P will be given to patients with congenital Factor XIII deficiency and congenital/acquired FXIII deficiency to prevent bleeding and to treat established bleeding episodes. For Factor XIII prophylaxis to prevent hemorrhages, the dosage will depend on the weight of the subject. The frequency of Factor XIII administration will be determined by the factor's circulating half-life. During the first month only, a Factor XIII pharmacokinetic study will be determined over a 4-week period. Safety data will include accrual of information on viral safety, liver function, complete blood counts and adverse events. Historical data concerning spontaneous bleeds will be collected whenever possible two years prior to treatment with Fibrogammin P.

Completed5 enrollment criteria

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor...

Congenital Bleeding DisorderCongenital FXIII Deficiency

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

Completed9 enrollment criteria

A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency

Factor XIII Deficiency

Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with potentially life-threatening bleeding. This study will evaluate the safety and recommended (best) amount or level of Factor XIII in a patient's blood. Factor XIII Concentrate (Human) is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works by assisting your blood in the usual clotting process, thereby preventing bleeding.

Completed18 enrollment criteria

A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

Factor XIII Deficiency

Congenital deficiency of factor XIII (FXIII) is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding. In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose that will best minimize the chance of bruising and bleeding.

Completed17 enrollment criteria

An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency...

Factor XIII Deficiency

Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding. In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate (Human) to patients until the product becomes commercially available in the United States.

Completed10 enrollment criteria

Factor XIII and Other Biomarkers in ST Segment Elevation Myocardial Infarction

Factor XIII DeficiencyST-Elevation Myocardial Infarction2 more

In medical practice, a combination of clinical exam, electrocardiograms, circulating biomarkers, and imaging is used to gain insights on the prognosis after myocardial infarction. Novel molecular non-invasive tools are needed that help clinicians overcome the adverse events of post-myocardial infarction remodelling and thereby achieve improved therapy for its prevention. Coagulation factor XIII (FXIII) decay has been linked to major adverse cardiac events (MACE) in patients with acute coronary syndromes. Given the correlation between both intramyocardial haemorrhage and microvascular damage with acute phase complications in ST-elevation myocardial infarction, we hypothesise that excessive FXIII decay within the first week may predict acute phase outcomes in these patients. If this holds true, FXIII determination could be used as diagnostic and prognostic tool.

Completed4 enrollment criteria

Impact of Acquired FXIII Deficiency on Morbidity and Mortality

Acquired Factor XIII Deficiency Disease

Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality

Completed2 enrollment criteria

Wound Healing Abnormalities in Major Abdominal Surgery

Impaired Wound HealingFactor XIII Deficiency

This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters.

Completed7 enrollment criteria

Factor XIII in Major Burns Coagulation

BurnsCoagulation Disorder3 more

Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.

Unknown status9 enrollment criteria

Factor XIII and Pulmonary Embolism in Neurosurgical Patients

Brain TumorVascular Lesion2 more

Two studies (Gerlach et al. 2000; Gerlach et al. 2002) described the impact of factor XIII on the risk of prospective hemorrhage for patients undergoing craniotomy. Since then, factor XIII is measured and substituted in various centers. Few reports support the idea of factor XIII being involved in the formation of deep venous thrombosis and pulmonary embolism. In this prospective observational study, patients undergoing craniotomy for brain tumors or vascular lesions are investigated concerning the incidence of postoperative pulmonary embolism in respect of possible risk factors (factor XIII activity levels, standard coagulation parameters, tumor entity, blood loss).

Unknown status4 enrollment criteria
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