TraumaPhase 3MAFODNCT05502809
Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding
A Phase 3 study testing Deep-frozen platelets in people with Trauma and Bleeding, run by Alrijne Ziekenhuis Leiderdorp.
Trial summary
Primarily due to its logistical advantages The Netherlands Armed Forces (NLAF) have been successfully using deep frozen (-80°C) platelets (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- Deep-frozen platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of 12 years or older
- Alive at hospital presentation
- Requiring massive transfusion including platelets
- Signed (deferred) consent
Who cannot join
- Known pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Haemostatic Effect of Deep-frozen Platelets Versus Room Temperature Stored Platelets in the Treatment of Traumatic or Vascular Bleeding. MAFOD: a Randomized Controlled Non-inferiority Trial
Primarily due to its logistical advantages The Netherlands Armed Forces (NLAF) have been successfully using deep frozen (-80°C) platelets (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for effectiveness and safety in the treatment of these type of patients is currently lacking. The MAssive transfusion of Frozen bloOD (MAFOD) trial is therefore designed to compare the haemostatic effect of DTCs versus room temperature stored platelets (RSP) in the treatment of trauma- and vascular bleeding.
- Being tested
- Deep-frozen platelets
- Keywords
- trauma, resuscitation, platelets, cryopreservation, haemorrhage
- Medical subject headings
- Wounds and Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep-frozen plateletsDrug
Also called Cryopreserved platelets
Cryopreserved platelets
| Study group | Role | What they receive |
|---|---|---|
| Deep-frozen platelets | Experimental | -80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates. Receives: Drug: Deep-frozen platelets |
| Room-temperature stored platelets | Active comparator | +22°C stored platelets Receives: Drug: Deep-frozen platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that achieved haemostasis and show signs of life.
Achieved haemostasis (yes/no) as defined a patient no further require erythrocyte transfusions for two hours;
Measured: At six hours
Secondary outcomes (19)
Time to heamostasis in minutes after arrival to the hospital
as defined as the time in minutes from arrival to the moment a patient received no further erythrocyte transfusions for two hours
Measured: 24 hours
Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)
Units
Measured: Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Transfused plasma
Units
Measured: Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Transfused platelets
Units
Measured: Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Fibrinogen administration in grams
(grams) including the amount of fibrinogen in plasma
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Laboratory haemoglobin
(mmol/L)
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Laboratory haematocrit
(L/L)
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Laboratory platelet count
(x10^9/L)
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Coagulation parameter Fibrinogen (clauss)
(g/L)
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter INR
International Normalized Ratio
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter aPTT
(seconds) Viscoelastic testing (ROTEM: measured by viscoelastic testing Extem, Intem, Fibtem, Heptem, Aptem
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM)
ROTEM Extem
Measured: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Overall mortality
Alive at discharge (yes/no)
Measured: 24 hours, 30 days
Mortality at Emergency Department
Alive after Emergency Department (yes/no)
Measured: During hospital stay
Mortality after surgey
Alive after surgery (yes/no)
Measured: Emergency Department
Time of death
hours:minutes
Measured: During hospital stay
Hospital length of stay
Number of days in hospital after admission (date of discharge minus date of admission to the hospital)
Measured: 24 hours, 30 days
ICU length of stay
Measured: 24 hours, 30 days
Occurence of transfusion reactions
Measured: 24 hours, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alrijne Ziekenhuis Leiderdorp
- Sponsor type
- Research network
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Femke Noorman, PhD, Study director, Military Blood Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502809
- Sponsor's protocol ID
- MAFOD
- Acronym
- MAFOD
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rijnhout TWH, Noorman F, van der Horst RA, Tan ECTH, Viersen VVA, van Waes OJF, van de Watering LMG, van der Burg BLSB, Zwaginga JJ, Verhofstad MHJ, Hoencamp R. The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding: MAFOD-study protocol for a randomized controlled non-inferiority trial. Trials. 2022 Sep 24;23(1):803. doi: 10.1186/s13063-022-06739-2.
PubMed 36153539
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Haemostatic Effect of Deep-frozen Platelets Versus Room Temperature Stored Platelets in the Treatment of Traumatic or Vascular Bleeding. MAFOD: a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05502809
- Acronym / sponsor ID
- MAFOD / MAFOD
- Keywords
- trauma, resuscitation, platelets, cryopreservation, haemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Alrijne Ziekenhuis LeiderdorpResearch network
- Collaborators
- Erasmus Medical Center
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primarily due to its logistical advantages The Netherlands Armed Forces (NLAF) have been successfully using deep frozen (-80°C) platelets (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for effectiveness and safety in the treatment of these type of patients is currently lacking. The MAssive transfusion of Frozen bloOD (MAFOD) trial is therefore designed to compare the haemostatic effect of DTCs versus room temperature stored platelets (RSP) in the treatment of trauma- and vascular bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep-frozen platelets | Experimental | Drug: Deep-frozen platelets-80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates. |
| Room-temperature stored platelets | Active comparator | Drug: Deep-frozen platelets+22°C stored platelets |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of 12 years or older
- Alive at hospital presentation
- Requiring massive transfusion including platelets
- Signed (deferred) consent
Key exclusion criteria (1 listed)
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep-frozen plateletsAlso: Cryopreserved plateletsCryopreserved platelets | Drug | Deep-frozen platelets, Room-temperature stored platelets |
Primary outcome
Percentage of patients that achieved haemostasis and show signs of life.
Time frame: At six hours
Achieved haemostasis (yes/no) as defined a patient no further require erythrocyte transfusions for two hours;
19 secondary outcomes
Time to heamostasis in minutes after arrival to the hospital
Time frame: 24 hours
Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)
Time frame: Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Transfused plasma
Time frame: Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Transfused platelets
Time frame: Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Fibrinogen administration in grams
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Laboratory haemoglobin
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Laboratory haematocrit
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Laboratory platelet count
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
Coagulation parameter Fibrinogen (clauss)
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter INR
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter aPTT
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM)
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Overall mortality
Time frame: 24 hours, 30 days
Mortality at Emergency Department
Time frame: During hospital stay
Mortality after surgey
Time frame: Emergency Department
Time of death
Time frame: During hospital stay
Hospital length of stay
Time frame: 24 hours, 30 days
ICU length of stay
Time frame: 24 hours, 30 days
Occurence of transfusion reactions
Time frame: 24 hours, 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 36153539Rijnhout TWH, Noorman F, van der Horst RA, Tan ECTH, Viersen VVA, van Waes OJF, van de Watering LMG, van der Burg BLSB, Zwaginga JJ, Verhofstad MHJ, Hoencamp R. The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding: MAFOD-study protocol for a randomized controlled non-inferiority trial. Trials. 2022 Sep 24;23(1):803. doi: 10.1186/s13063-022-06739-2.
- Individual participant dataSharing planned: No
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Femke Noorman, PhD study director
Military Blood Bank
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deep-frozen platelets in people with Trauma and Bleeding, run by Alrijne Ziekenhuis Leiderdorp.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim Rijnhout (0715828282, twhrijnhout@alrijne.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that achieved haemostasis and show signs of life. (time frame: At six hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.