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Efficacy and safety of using fibrinogen concentration during prehospital transport in Trauma Patients at Risk for Hemorrhagic Shock

Efficacy and safety of using fibrinogen concentration during prehospital transport in Trauma Patients at Risk for Hemorrhagic Shock

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074664
Enrollment
Unknown
Registered
2023-08-11
Start date
2023-08-13
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Interventions

Human fibrinogen group:Enrolled patients were given human fibrinogen according to their weight (3 g for patients weighing 30-60 kg, 4.5 g for patients weighing 60-90 kg, and 6 g for patients weighing
after admission to the trauma center, follow the trauma resuscitation process for further treatment
Control group:The maximum amount of crystal fluid should not exceed 20 ml kg

Sponsors

The Second Affiliated Hospital, Hengyang Medical School, University of South China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 14-80 years, male or female; 2) any of the following conditions prior to transfer to a trauma center: A. At least one episode of hypotension (systolic blood pressure 108 beats per minute);. Severe hypotension (systolic blood pressure 60 years old), 3) the patients or their family members informed and voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) pregnancy. 2) traumatic cardiac arrest. 3) neurogenic shock; 4) patients who can not establish venous access during transportation.5) injury time > 24 hours.6) transfer to other medical institutions.7) have received treatment in other medical institutions; 8) complicated with other serious diseases, including respiratory, circulatory, digestive, urinary, endocrine, immune, or blood system; 9) severe liver damage, ALT, or AST3 upper limit of ordinary, severe renal insufficiency, GFR < 30 ml/(min · 1.73 m ^ 2).10) patients with severe advanced cognitive impairment (e.g., AD) or psychiatric disorders who can not complete the follow-up plan as required.11) those with current drug or alcohol abuse or dependence, or those with communication difficulties who are expected to have poor compliance, or who do not use a cell phone, or whose address is too remote to be expected to complete follow-up in the future.12) any other situation in which the investigator believes that starting the study treatment would cause significant harm to the subject. 13) are participating in other clinical trials. (excl. Observational studies not involving intervention, epidemiological investigations)

Design outcomes

Primary

MeasureTime frame
28-day mortality rate;1-day mortality rate;

Countries

China

Contacts

Public ContactYong Luo

The Second Affiliated Hospital, Department of Emergency, Hengyang Medical School, University of South China, Jiefang Avenue, Zhengxiang District, 421001 Hengyang, Hunan, China.

fordluo@qq.com+86 185 0734 1508

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026