Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting

Vastra Gotaland Region

Status and phase: Not yet enrolling; Phase 4

Conditions: Blunt Injury; Gastrointestinal Hemorrhage; Aortic Rupture; Penetrating Injury; Obstetric Bleeding; Bleeding

Treatments: Biological: Dry plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT07012863

LBTSB

Details and patient eligibility

About

The overall goal of this clinical trial is to study how prehospital transfused dry plasma affect outcomes in terms of mortality as well as complications and coagulation status of patients in or about to develop bleeding shock.

Researchers will compare dry plasma to standard care to see if dry plasma improves survival compared to crystalloid fluid in prehospital patients with heavy bleeding.

Full description

Major haemorrhage remains one of the leading causes of preventable early death after injury, and the window for effective intervention often closes in the pre-hospital phase. Contemporary European guidelines therefore advocate damage-control resuscitation: permissive hypotension, minimal crystalloid use and early infusion of blood components to avoid dilutional coagulopathy, acidosis and hypothermia. Several reports support that early resuscitation with blood products may save lives.

Freeze- or spray dried plasma containing coagulation factors having up to two years storage time and the possibility of storing ambient temperature, may be an alternative to crystalloids. The results regarding the beneficial results of treatment with plasma are ambiguous. In a previous randomized study using fresh plasma versus crystalloids, 9,8% reduced mortality was shown with resuscitation with plasma. Lower INR and lactate were also seen among the patients treated with plasma. In some studies no effect on mortality could be shown, but in other studies it is suggested that plasma may be beneficial in long transport time.

Acute traumatic coagulopathy can be seen in at least 25 % of severely injured patients who are admitted to a trauma centre. Dilution is often considered as a likely cause although the exact mechanisms and level of aggravation is unknown.

Most studies of prehospital bleeding refer to trauma, but also other causes of bleeding can be severe and even fatal, especially in countries with long distances, e.g. obstetric bleeding, gastrointestinal bleeding and vascular catastrophes.

Hypothesis. The hypothesis of this study is that prehospital treatment with dry plasma to bleeding patients improves the outcome compared to patients receiving standard treatment in terms of lower mortality, lower degree of coagulopathy and less need for blood products when in hospital.

Study aim. The aim of this study is to report outcome for patients receiving standard treatment for major prehospital bleeding compared to patients receiving standard care and to report clinical data for both groups.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with clinical signs of bleeding which also triggers resuscitation with crisalloids acording to standard care protocol.

Exclusion criteria

• Patients < 18 years of age.
• Patients who lack clinical signs of major bleeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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650 participants in 2 patient groups

Standard care

No Intervention group

Description:

Patients randomized to this arm will get standard treatment within the ambulance service

Dry plasma

Active Comparator group

Description:

Patients randomized to this arm will get dry plasma as treatment for the bleeding.

Treatment:

Biological: Dry plasma