Severe bleeding with abnormal coagulation
Conditions
Interventions
none:none
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Signed informed consent 2.At least 18 years of age 3.Expected ICU stay >24 hours 4.Bleeding event * (within 24 hours) 5.There are coagulation abnormalities * (low fibrinogen or consistent with the diagnosis of coagulation disease). Note 1: Bleeding event * : There is clinical bleeding event, in the absence of other conditions, the patient meets one of the following criteria: 1.Surgical bleeding, intraoperative infusion of more than 2U units of RBC or whole blood, or postoperative Hb decline of more than 2g/L; 2.Non-surgical bleeding, requiring infusion of more than 2U RBC or whole blood; Hb decreased by more than 2g/L; 3.Symptomatic bleeding in key areas or key organs *; 4.Bleeding events require invasive intervention; 5.Haemorrhage leading to hypovolemic shock (systolic blood pressure 40mmHg); 6.Bleeding leads to a decrease in systolic blood pressure of more than 20mmHg or an increase in heart rate of at least 20 beats /min. Bleeding that did not meet these criteria was defined as minor bleeding and was not included in the study. Note 2: Abnormal coagulation * (low fibrinogen or meeting the diagnosis of coagulopathy) : one of the following criteria is met: 1.Low fibrinemia occurs: FIB(fibrinogen level) 1.5 times the normal value; Or PT>16s; Or INR>1.5; 2.APTT (activated partial thrombin time) > 1.5 times the normal value; Or APTT>60s. Note 3: Critical site * : Bleeding that impairs organ function is considered critical site * bleeding, such as intracranial bleeding and other central nervous system bleeding (e.g., intraocular bleeding, spinal cord bleeding). Thoracic, airway, pericardium, intraperitoneal, retroperitoneal, intra-articular and intramuscular bleeding are considered to be critical site bleeding.
Exclusion criteria
Exclusion criteria: 1. Patients receiving palliative care or expected to die within 48 hours; 2. Pregnant or lactating women; 3. any known congenital coagulation disorder; 4. does not meet the definition of bleeding events; 5. It does not meet the diagnostic criteria of hypofibrinogenemia and coagulation disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day mortality;amount of bleeding; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibrinogen level changes;Changes in coagulation function;Quantity and type of blood products used;hemodynamic change;ICU stay/total length of stay;Thromboembolic event; | — |
Countries
China
Contacts
Public ContactZhigang Chang
Beijing Hospital
Outcome results
None listed