the primary aim is to determine the effect of thawed deep-frozen platelets re-suspended in thawed deep-frozen plasma versus room temperature stored platelets in platelet additive solution for transfusion on the percentage of patients with surgical…
ID
Source
Brief title
Condition
- Other condition
- Vascular injuries
Synonym
Health condition
Massaal bloedverlies ten gevolge van traumatisch letsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the percentage of patients achieved haemostasis at six hours
(360 minutes) (as defined as the time in minutes from MTP activation to the
moment a patient received no further blood product transfusions for two hours).
Secondary outcome
The secondary aims are
- Time to haemostasis (as defined as the time in minutes from MTP activation to
the moment a patient received no further blood product transfusions for two
hours)
- Total in-hospital blood component consumption (units)
- Fibrinogen administration (including blood component content)
- Laboratory parameters (e.g. platelet count, Haematocrit)
- Coagulation parameters (INR, fibrinogen levels, ROTEM® parameters).
- Mortality
- Hospital lenght of stay
- Intensive care lenght of stay
- Transfusion reactions
Background summary
Patients with surgical bleeding often require massive transfusion. The current
standard advises to transfuse blood components in a balanced ratio (1:1:1 -
erythrocytes:plasma:platelets) that equalizes whole blood transfusion. The
Dutch-Ministry of Defence uses deep frozen platelets primarily due to
logistical advantages. These deep-frozen platelets are associated with improved
haemostasis and reduced in hospital blood product consumption in vitro and
animal studies in comparison with liquid room stored (+22°C) buffy coat room
temperature stored platelets. However, high quality evidence for usage of
deep-frozen platelets in clinical trials is still scarce.
Study objective
the primary aim is to determine the effect of thawed deep-frozen platelets
re-suspended in thawed deep-frozen plasma versus room temperature stored
platelets in platelet additive solution for transfusion on the percentage of
patients with surgical bleeding achieved haemostasis at six hours (360
minutes) (haemostasis is defined that a patient no further requires
erythrocyte transfusion for two hours) The secondary aims are to determine the
effect of thawed deep-frozen platelets re-suspended in thawed deep-frozen
plasma versus room temperature stored platelets in platelet additive solution
for transfusion in patients with surgical bleeding on (1) time to haemostasis
(as defined as the time in minutes from MTP activation to the moment that a
patient no further requires erythrocyte transfusion for two hours); (2) total
in hospital transfused blood component consumption in different time intervals
(up to 30-days or discharge); (3) fibrinogen administration in different time
intervals (content of all blood products calculated measured according to
previous research); (4) Laboratory parameters for blood gasses and electrolytes
in different time intervals; (5) coagulation parameters in different time
intervals; (6) mortality at 1, 3, 6, 12, 24 and 72 hours and 30-days; (7)
hospital length of stay up to 30-days or discharge; (8) ICU stay up to 30-days
or discharge; (9) occurrence of transfusion reactions.
Study design
Single blind randomized controlled non-inferiority trial
Intervention
transfusion with thawed deep-frozen platelets re-suspended in thawed
deep-frozen plasma or transfusion with room temperature stored platelets in
platelet additive solution in the first 48 hours after MTP activation.
Study burden and risks
The known burden and risks are not greater than the currently used blood
platelets. The hypothesis is that patients who received deep-frozen platelets
achieve hemostasis earlier. This is advantageous since, in addition to the
possible survival advantage, less blood products are required which will result
in a cost reduction.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Patients of 12 years or older*
2. Alive at hospital presentation
3. Order of massive transfusion package including platelet concentrate for
surgical bleeding (e.g. traumatic bleeding or bleeding in transplantation
surgery)
4. Signed deferred consent by patient, proxy, or parents, as applicable.
* it is imaginable that the exact age of a child at presentation on the
emergency department is not known. At a confirmed age younger than 12, the
patient will be excluded from analysis.
Exclusion criteria
- Refusal of blood product administration (e.g. confirmed prior to
randomisation in the electronic patient file that patient is a Jehovah*s
Witness)
- Known pregnancy
- Known to refuse resuscitation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75412.078.21 |