A Phase 4 interventional study of Dry plasma in Bleeding, Aortic Rupture and Gastrointestinal Hemorrhage, sponsored by Vastra Gotaland Region. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Vastra Gotaland Region · Phase 4, Interventional, and Treatment
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.
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.
338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 650 is above the median of 98 across 210 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Vastra Gotaland Region is the lead sponsor of 275 studies on the registry; 109 are open to participants now.
Compared within Gastrointestinal Hemorrhage, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hemorrhage. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients randomized to this arm will get standard treatment within the ambulance service
Patients randomized to this arm will get dry plasma as treatment for the bleeding.
Biological: Dry plasma
Patient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention.
Mortality
Overall mortality at 24 hours after hospital admission. Will include patients dead at scene or during transportation.
Time frame: Within 24 hours after hospital admission.
Mortality for patients with bleeding > 500 mL (milliliter)
Specific mortality for patients with a bleeding \> 500mL at 24 hours after hospital admission. Will include patients dead at scene or during transport.
Time frame: Within 24 hours after hospital admission
Shock Index
Shock Index \> 1.3.
Time frame: baseline, pre-intervention at scene
Coagulopathy overall
PK/INR \> 1.2 and/or Platelet count \< 150 x 109/L and/or APTT \> 34 s or each valuable alone. INR= international normalized ratio PK= prothrombin complex. APTT= activated partial thromboplastin time.
Time frame: Measured at hospital admission
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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