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Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death.
The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Experimental | Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive Fibrinogen concentrate after common emergency resuscitation. Instruction:
Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight)) |
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| Control group | Active Comparator | Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RiaSTAP Injectable Product | Drug | RiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes. Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight)) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate. | Mortality rate after injection of fibrinogen concentrate. | Until 90 days after admission. |
| Average of serum fibrinogen level. | Average of serum fibrinogen level in iTBI patient. | Immediately after admission. |
| The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage). | The need to packed cell, FFP, Platelete. | 2, 6, 24, 72 hours and 30 , 90 days after admission. |
| Measure | Description | Time Frame |
|---|---|---|
| The complications that related to fibrinogen concentrate. | like DVT, PTE, MI.by measurement of serum D-dimer for DVT and PTE and serum Troponin C for MI. | until 90 days after admission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahdi Vahidian, Student | Contact | +989103374626 | Mehdivahid2@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isfahan university of medical science. | Recruiting | Isfahan | Iran |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |