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Effect of Prothrombin Complex Concentrate Combined with Plasma in Trauma-Induced Bleeding

Efficacy and Safety of Prothrombin Complex Concentrate Combined with Fresh Frozen Plasma versus Fresh Frozen Plasma Alone in Patients with Trauma-Induced Coagulopathy: A Prospective Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125118
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-05-23
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Trauma-induced coagulopathy

Interventions

Intervention group (PCC + FFP):Prothrombin complex concentrate (10–20 IU/kg, adjusted according to coagulation status and bleeding severity) combined with fresh frozen plasma, in addition to standard
Control group (FFP alone):Fresh frozen plasma alone based on clinical requirements, in addition to standard trauma care.

Sponsors

Haining People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants must meet all of the following conditions to be eligible for this study: 1. Voluntarily agree to participate in this study and sign the informed consent form. 2. Hospitalized patients aged 18 years or older, of any sex. 3. Patients diagnosed with traumatic coagulopathy, meeting either of the following: (1) Laboratory criteria (any one of the following): 1) PT > 18 s 2) APTT > 60 s 3) TT > 15 s 4) PTr > 1.6 (2) Presence of active or potential bleeding, requiring blood products or replacement therapy.

Exclusion criteria

Exclusion criteria: 1.Patients with cardiac arrest before enrollment; 2.Patients expected to die within 1 hour after admission; 3.Patients transferred from other medical institutions; 4.Patients receiving anticoagulant therapy before injury; 5.Pregnant or lactating women; 6.Known allergy to prothrombin complex concentrate or its components; 7.Participation in another clinical trial within the past 30 days; 8.Any other condition considered unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
Total blood product consumption within 48 hours;

Secondary

MeasureTime frame
Changes in coagulation parameters;Thromboelastography parameters;Inflammatory markers;

Countries

China

Contacts

Public ContactXiaoxia Li

Haining People’s Hospital

lihaha0805@163.com+86 138 5732 5499

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026