Patients with thrombocytopenia or coagulation factor disorders
Conditions
Interventions
transfusion group guided by conventional coagulation tests (CCT) (i.e., transfusion decisions based solely on CCT results, including the six coagulation parameters and platelet count) :Observational s
the transfusion group guided by Century clot(R) CPA testing (i.e., patients for whom at least one transfusion decision was made based on Century clot(R) CPA test results):Observational study involves
Sponsors
Department of Blood Transfusion, The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
15 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients with severe trauma (1) Aged 18 to 85 years; (2) Meeting any of the following injury conditions: penetrating torso injury, unstable pelvic fracture, suspected bleeding in a region indicated by abdominal ultrasound, or trauma with clinical signs of hemorrhage; (3) Meeting any of the following criteria: prehospital systolic blood pressure = 15 upon admission, or injured patients meeting the criteria for activating the local massive transfusion protocol. 2. Patients with hematological diseases Meeting any of the following criteria: (1) Diagnosed with hematological malignancies requiring platelet transfusion (such as leukemia, lymphoma, or multiple myeloma) or other hematological disorders (e.g., immune thrombocytopenia or hemolytic anemia); (2) Patients with hematological diseases presenting with a risk of bleeding or active bleeding. 3. Patients with liver diseases (1) Aged 18 to 85 years; (2) Meeting any of the following criteria: Patients with chronic liver disease and severe coagulation disorders (defined as platelet count 1.8), patients with compensated or decompensated liver cirrhosis or hepatocellular carcinoma, patients with acute liver failure or acute-on-chronic liver failure, or patients with liver diseases requiring invasive procedures (non-major surgery). 4. Patients with perioperative bleeding (1) Patients undergoing cardiac surgery: 1) Undergoing cardiac surgery; 2) Receiving cardiopulmonary bypass (CPB) during the perioperative period. (2) Patients undergoing liver transplantation surgery; (3) Patients undergoing kidney transplantation surgery; (4) Other patients with perioperative bleeding. 5. Patients with sepsis (1) Aged 15 to 85 years; (2) Meeting the diagnostic criteria for sepsis or septic shock.
Exclusion criteria
Exclusion criteria: 1. Patients with severe trauma (1) Preexisting congenital coagulation disorders; (2) Primary impairment of liver function; (3) Use of anticoagulant medication within the previous 6 months; (4) Prior treatment with antithrombin or activated protein C; (5) Receipt of > 2000 mL of crystalloids, colloids, or blood components prior to hospital admission; (6) Presence of severe brain injury (defined as: Glasgow Coma Scale [GCS] score of 3 due to brain injury, requirement for emergency neurosurgery, presence of focal signs such as unequal pupils, or intracranial hemorrhage with mass effect on computed tomography), catastrophic brain injury (defined as: penetrating gunshot wound to the head, open skull fracture with exposed or missing brain tissue, or judgment by an expert based on initial clinical or CT findings), asphyxiation due to drowning or hanging, or burns covering > 20% of total body surface area; (7) Pregnancy or incarceration; (8) Death within 24 hours after admission; (9) Patients who did not undergo any of the following examinations: CCT and Century clot® CPA testing; (10) Inability to establish intravenous access or presence of non-hemorrhagic shock (i.e., cardiogenic, septic, neurogenic, or obstructive [cardiac tamponade, tension pneumothorax, or massive pulmonary embolism]). 2. Patients with hematological diseases (1) Patients without a definitive diagnosis or without a confirmed diagnosis of hematological disease based on the most recent complete blood count; (2) Patients undergoing plasma exchange, lymphoplasma exchange, or whole blood exchange; (3) Pregnancy; (4) Patients who did not undergo any of the following examinations: CCT and Century clot® CPA testing. 3. Patients with liver diseases (1) Patients undergoing liver transplantation or other major surgery; (2) Patients undergoing plasma exchange or artificial liver support; (3) Presence of malignancies other than hepatocellular carcinoma, disseminated intravascular coagulation (DIC), or known coagulation disorders; (4) Use of platelet inhibitors (e.g., aspirin, clopidogrel) and/or medications affecting the coagulation cascade (e.g., vitamin K antagonists) within 7 days of admission; (5) Pregnancy; (6) Presence of shock at admission (systolic blood pressure < 90 mmHg); (7) Presence of sepsis; (8) Acute kidney injury requiring renal replacement therapy or chronic renal failure; (9) Patients who did not undergo any of the following examinations: platelet count, CCT, and Century clot® CPA testing. 4. Patients with perioperative bleeding (1) Patients who did not undergo any of the following examinations: CCT and Century clot® CPA testing. 5. Patients with sepsis (1) Prior receipt of anticoagulation therapy; (2) Diagnosis of chronic liver or kidney disease; (3) Death within 24 hours after admission; (4) Patients who did not undergo any of the following examinations: CCT and Century clot® CPA testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of various blood components used during hospitalization;Cost-effectiveness analysis (Costs: documentation of transfusion costs, ICU costs, and various other medical resource costs; Benefits: length of ICU stay, length of hospital stay, incidence of MODS, MOF, or ARDS, duration of mechanical ventilation, in-hospital mortality rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of organ dysfunction or failure, infection, and bleeding; in-hospital mortality rate;the use of antifibrinolytic and procoagulant drugs;thromboembolic events;the incidence of transfusion-related adverse reactions; | — |
Countries
China
Contacts
Public ContactRongGui
The Third Xiangya Hospital of Central South University
Outcome results
None listed