Effect of Qishen Huoxue Granules on coagulopathy/early DIC in sepsis and its mechanism

Phase 1

Recruiting

• Conditions: sepsis

• Registration Number: ITMCTR2100004537
• Lead Sponsor: Beijing Friendship Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adults >= 18 years old, meet SEPSIS 3.0 diagnostic criteria and have coagulopathy/early DIC. 1) Sepsis inclusion criteria, according to SEPSIS 3.0 diagnostic criteria. 2) Coagulation disorders/early DIC, refer to the International Society of Thrombosis and Hemostasis DIC scoring system (ISTH) for diagnosis. DIC scores of 3 to 4 are included.

Exclusion Criteria

1) Pregnant or breastfeeding women;
2) Aged < 18 years;
3) Platelets < 30,000/L;
4) Patient has life-threatening active bleeding;
5) 12 hours before and after major surgery on chest, abdomen, skull, peripheral blood vessels and other parts Internal;
6) a history of severe brain injury and intracranial surgery;
7) intracranial vascular malformations, cerebral hemangioma, large central central lesions and stroke within three months;
8) hemophilia and other congenital coagulation diseases;
9) The patients previous severe liver cirrhosis, esophageal varices or bleeding history and current ascites;
10) Severe gastrointestinal, respiratory, urinary tract bleeding, gastrointestinal leakage; a history of gastrointestinal, urinary tract bleeding within 6 weeks Hemorrhage in the tract or respiratory tract requires special treatment;
11) have used aspirin > 650 mg/d or warfarin in the past 7 days, or have undergone thrombolytic therapy in the past 1 month;
12) the patient is dying (estimated Died within 6 hours);
13) Known or suspected brain death;
14) Is undergoing dialysis treatment;
15) The patient is undergoing other treatment studies that may interfere with this study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
platelet;D-Dimer;Thymidine phosphorylase;HMGB1;PT;Fibrinogen;

Secondary Outcome Measures

Name	Time	Method
Creatinine;Aspartate aminotransferase;AT III;Bilirubin;Procalcitonin;Heparin binding protein;Interleukin 10;Alanine aminotransferase;