HypofibrinogenemiaPhase 2EDIPORENCT05780125
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
A Phase 2 study testing FibCLOT and RiaSTAP in people with Hypofibrinogenemia and Surgical Blood Loss, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RiaSTAP (CSL Behring), FIBRYGA (Octapharma), and FibCLOT (LFB). RiaSTAP and FIBRYGA are sold in 1-gram vials, and FibCLOT - in 1.5-gram vials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypofibrinogenemia, Surgical Blood Loss, Bleeding
- What is being tested?
- FibCLOT and RiaSTAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2023to 6 Feb 2024
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cardiac surgery with cardiopulmonary bypass;
- complex cardiac surgery (coronary artery bypass graft + valve repair/replacement; double/triple valve repair/replacement; ascendant aorta surgery);
- written consent to participate;
Who cannot join
- urgent or emergent cardiac surgery;
- known hypersensitivity to the active principle or to one of the excipients of the study drugs;
- coagulation disorders, known or presumable from anamnesis;
- known hepatopathy;
- known risk of thrombosis or disseminated intravascular coagulation;
- participation in another clinical study where an experimental product has been administered within 30 days from the day of the inclusion in the study;
- whatever clinical condition that, in the opinion of the investigator, makes the patients not suitable to the experimentation.
Trial locations and contacts
1 site in 1 country.
About this study
Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RiaSTAP (CSL Behring), FIBRYGA (Octapharma), and FibCLOT (LFB). RiaSTAP and FIBRYGA are sold in 1-gram vials, and FibCLOT - in 1.5-gram vials. A recent in vitro study assessed how these products affected the clot firmness measured by the ROTEM FIBTEM maximum clot firmness (MCF) parameter. In vitro conditions, FibCLOT was verified to be the most efficient in increasing clot firmness.
The present study is aimed to assess, in a series of patients undergoing cardiac surgery with cardiopulmonary bypass, the hypothesis that the FibCLOT fibrinogen is superior to the RiaSTAP fibrinogen in increasing the FIBTEM MCF parameter in a clinical model of bleeding (postoperative bleeding after complex cardiac surgery).
Read the detailed description
The Effectiveness of DIfferent fibrinogen PreparatiOns in Restoring clot firmness (EDIPO RE) is a pragmatic, double-blinded, randomized controlled trial testing the hypothesis that FibCLOT is superior to RiaSTAP in restoring fibrinogen-dependent clot firmness in cardiac surgery acquired hypofibrinogenemia.
A randomization sequence was generated by a computerized system, and then sealed envelopes containing the drug assigned were prepared. The randomization ratio of the treatment arms was 1:1. An unblinded biologist was in charge of running the ROTEM® tests, randomization, drug preparation, and masking, and its delivery to the operating room. The attending anesthesiologist, the surgical staff, and the medical staff in the ICU and ward were blinded.
After protamine administration, if microvascular bleeding was observed or suspected, POC testing, including ROTEM® EXTEM and FIBTEM, was run. If FIBTEM MCF was lower than 10 mm, the patient was randomly allocated to receive a dose of RiaSTAP® or FibCLOT® of 30 mg/kg, approximated to the closest between 2 or 3 grams. If no sign of ongoing bleeding was present, or FIBTEM MCF was 10 mm or higher the patient was considered screen failure and excluded from further observation.
Forty patients were randomized to receive the assigned treatment.
Fibrinogen was administrated intravenously by infusion at a rate of approximately 20 ml/min. Ten minutes after fibrinogen administration a second test was performed with ROTEM® EXTEM and FIBTEM tests to record the change of the parameters due to fibrinogen supplementation. No other hemostatic drugs nor transfusions, outside the study drug, were administered between the first and the second testing. In case of ongoing intra- or postoperative bleeding, after the second testing, all the hemostatic corrections were allowed and guaranteed by our institutional protocol for postoperative bleeding management, which includes the following step-by-step interventions:
- 30-50 mg of additional protamine for the correction of residual heparin, if the CT at INTEM exceeded 20% of the CT at HEPTEM;
- Additional fibrinogen concentrate, if FIBTEM MCF < 10 mm or Clauss fibrinogen < 150 mg dL-1;
- Platelet concentrates if P2Y12 receptor inhibitors were discontinued not later than 7 days, a postoperative ADP test at Multiplate® aggregometry < 12 U, or a postoperative platelet count measured or presumed from preoperative count <100,000 cells/µL;
- 4-factors prothrombin complex concentrate (PCC, Pronativ, Octapharma, Lachen, Switzerland) 20 IU kg-1 if EXTEM CT > 100 s (after correction of fibrinogen and platelet values) or INR > 1,5.
Preoperative, and perioperative data and details of postoperative outcomes were retrieved from our institutional database and patients' medical charts, including demographics, preoperative risk factors, procedure details, postoperative bleeding and transfusions, intensive care unit (ICU), and hospital stay duration. For the study, the following additional data have been collected: preoperative fibrinogen, platelet count, coagulation parameters (prothrombin time, PT; international normalized ratio, INR; activated partial thromboplastin time, aPTT), post protamine EXTEM CT and MCF and FIBTEM MCF; post-fibrinogen supplementation EXTEM CT and MCF and FIBTEM MCF; fibrinogen, platelet count and coagulation at the ICU arrival.
- Conditions
- Hypofibrinogenemia, Surgical Blood Loss, Bleeding, Cardiac Disease, Surgery
- Being tested
- FibCLOT, RiaSTAP
- Keywords
- hypofibrinogenemia, cardiac surgery, postoperative bleeding
- Medical subject headings
- Afibrinogenemia, Blood Loss, Surgical, Hemorrhage, Heart Diseases, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibCLOTDrug
Also called Human Fibrinogen concentrate
30 mg/kg of FibCLOT (rounded up to the nearest 2 or 3 grams) after protamine administration
RiaSTAPDrug
Also called Human Fibrinogen concentrate
30 mg/kg of RiaSTAP (rounded up to the nearest 2 or 3 grams) after protamine administration
| Study group | Role | What they receive |
|---|---|---|
| FibCLOT | Experimental | Patients randomized to the FibCLOT arm will receive 30 mg/kg, approximated to the closest between 2 and 3 grams, of FibCLOT (LFB, Puteaux, France). Receives: Drug: FibCLOT |
| RiaSTAP | Active comparator | Patients randomized to the RiaSTAP arm will receive 30 mg/kg, approximated to the closest between 2 and 3 grams, of RiaSTAP (King of Prussia, PA, USA). Receives: Drug: RiaSTAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIBTEM MCF (mm)
Fibrinogen contribution to the clot firmness measured by ROTEM device, as maximum clot firmness parameter).
Measured: Within 10 minutes after protamine administration
FIBTEM CT and CFT (sec)
Fibrinogen contribution to the clot firmness measured by ROTEM device, as time required for clot formation (CT, clotting time, and CFT, clot formation time).
Measured: Within 10 minutes after protamine administration
EXTEM CT and CFT (sec)
Time required for the overall clot formation on the extrinsic pathway of coagulation ( CT, clotting time, and CFT, clot formation time).
Measured: Within 10 minutes after protamine administration
Secondary outcomes (3)
Postoperative bleeding
Amount of postoperative bleeding measured by the cardiac drainages
Measured: 12 and 24 hours after surgery
Incidence of moderate/severe bleeding
Number of cases of moderate or severe bleeding, as defined by the Universal Definition of Perioperative bleeding
Measured: 12 hours after surgery
Incidence of transfusion
Number of cases requiring the transfusion of red blood cells and platelet concentrates
Measured: 12 and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start20 Mar 2023
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypofibrinogenemiaStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blind, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranucci, IRCCS Policlinico S. Donato
- Investigators
- Marco Ranucci, MD, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780125
- Sponsor's protocol ID
- EDIPORE
- Acronym
- EDIPORE
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ranucci M, Baryshnikova E. Fibrinogen supplementation after cardiac surgery: insights from the Zero-Plasma trial (ZEPLAST). Br J Anaesth. 2016 May;116(5):618-23. doi: 10.1093/bja/aev539. Epub 2016 Feb 17.
PubMed 26893405Stolt H, Shams Hakimi C, Singh S, Jeppsson A, Karlsson M. A comparison of the in vitro effects of three fibrinogen concentrates on clot strength in blood samples from cardiac surgery patients. Acta Anaesthesiol Scand. 2021 Nov;65(10):1439-1446. doi: 10.1111/aas.13967. Epub 2021 Sep 1.
PubMed 34368944Scolletta S, Simioni P, Campagnolo V, Celiento M, Fontanari P, Guadagnucci A, Guarracino F, Haxhiademi D, Paniccia R, Simeone F, Ranucci M; Granducato Research Group. Patient blood management in cardiac surgery: The "Granducato algorithm". Int J Cardiol. 2019 Aug 15;289:37-42. doi: 10.1016/j.ijcard.2019.01.025. Epub 2019 Jan 11.
PubMed 30711263Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Cardiothorac Vasc Anesth. 2021 Sep;35(9):2569-2591. doi: 10.1053/j.jvca.2021.03.011. Epub 2021 Jun 30. No abstract available.
PubMed 34217578Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9.
PubMed 24332097Baryshnikova E, Aloisio T, Di Dedda U, Anguissola M, Barbaria A, Caravella G, Ranucci M. A Randomized Controlled Trial Comparing Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness. Anesth Analg. 2025 Apr 1;140(4):966-973. doi: 10.1213/ANE.0000000000007201. Epub 2024 Oct 9.
PubMed 39383100
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
- ClinicalTrials.gov ID
- NCT05780125
- Acronym / sponsor ID
- EDIPORE / EDIPORE
- Conditions
- Hypofibrinogenemia, Surgical Blood Loss, Bleeding, Cardiac Disease, Surgery
- Keywords
- hypofibrinogenemia, cardiac surgery, postoperative bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 22 Mar 2023 (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.
Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RiaSTAP (CSL Behring), FIBRYGA (Octapharma), and FibCLOT (LFB). RiaSTAP and FIBRYGA are sold in 1-gram vials, and FibCLOT - in 1.5-gram vials. A recent in vitro study assessed how these products affected the clot firmness measured by the ROTEM FIBTEM maximum clot firmness (MCF) parameter. In vitro conditions, FibCLOT was verified to be the most efficient in increasing clot firmness.
The present study is aimed to assess, in a series of patients undergoing cardiac surgery with cardiopulmonary bypass, the hypothesis that the FibCLOT fibrinogen is superior to the RiaSTAP fibrinogen in increasing the FIBTEM MCF parameter in a clinical model of bleeding (postoperative bleeding after complex cardiac surgery).
Detailed description
The Effectiveness of DIfferent fibrinogen PreparatiOns in Restoring clot firmness (EDIPO RE) is a pragmatic, double-blinded, randomized controlled trial testing the hypothesis that FibCLOT is superior to RiaSTAP in restoring fibrinogen-dependent clot firmness in cardiac surgery acquired hypofibrinogenemia.
A randomization sequence was generated by a computerized system, and then sealed envelopes containing the drug assigned were prepared. The randomization ratio of the treatment arms was 1:1. An unblinded biologist was in charge of running the ROTEM® tests, randomization, drug preparation, and masking, and its delivery to the operating room. The attending anesthesiologist, the surgical staff, and the medical staff in the ICU and ward were blinded.
After protamine administration, if microvascular bleeding was observed or suspected, POC testing, including ROTEM® EXTEM and FIBTEM, was run. If FIBTEM MCF was lower than 10 mm, the patient was randomly allocated to receive a dose of RiaSTAP® or FibCLOT® of 30 mg/kg, approximated to the closest between 2 or 3 grams. If no sign of ongoing bleeding was present, or FIBTEM MCF was 10 mm or higher the patient was considered screen failure and excluded from further observation.
Forty patients were randomized to receive the assigned treatment.
Fibrinogen was administrated intravenously by infusion at a rate of approximately 20 ml/min. Ten minutes after fibrinogen administration a second test was performed with ROTEM® EXTEM and FIBTEM tests to record the change of the parameters due to fibrinogen supplementation. No other hemostatic drugs nor transfusions, outside the study drug, were administered between the first and the second testing. In case of ongoing intra- or postoperative bleeding, after the second testing, all the hemostatic corrections were allowed and guaranteed by our institutional protocol for postoperative bleeding management, which includes the following step-by-step interventions:
- 30-50 mg of additional protamine for the correction of residual heparin, if the CT at INTEM exceeded 20% of the CT at HEPTEM;
- Additional fibrinogen concentrate, if FIBTEM MCF < 10 mm or Clauss fibrinogen < 150 mg dL-1;
- Platelet concentrates if P2Y12 receptor inhibitors were discontinued not later than 7 days, a postoperative ADP test at Multiplate® aggregometry < 12 U, or a postoperative platelet count measured or presumed from preoperative count <100,000 cells/µL;
- 4-factors prothrombin complex concentrate (PCC, Pronativ, Octapharma, Lachen, Switzerland) 20 IU kg-1 if EXTEM CT > 100 s (after correction of fibrinogen and platelet values) or INR > 1,5.
Preoperative, and perioperative data and details of postoperative outcomes were retrieved from our institutional database and patients' medical charts, including demographics, preoperative risk factors, procedure details, postoperative bleeding and transfusions, intensive care unit (ICU), and hospital stay duration. For the study, the following additional data have been collected: preoperative fibrinogen, platelet count, coagulation parameters (prothrombin time, PT; international normalized ratio, INR; activated partial thromboplastin time, aPTT), post protamine EXTEM CT and MCF and FIBTEM MCF; post-fibrinogen supplementation EXTEM CT and MCF and FIBTEM MCF; fibrinogen, platelet count and coagulation at the ICU arrival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, double-blind, randomized
| Arm | Type | Receives |
|---|---|---|
| FibCLOT | Experimental | Drug: FibCLOTPatients randomized to the FibCLOT arm will receive 30 mg/kg, approximated to the closest between 2 and 3 grams, of FibCLOT (LFB, Puteaux, France). |
| RiaSTAP | Active comparator | Drug: RiaSTAPPatients randomized to the RiaSTAP arm will receive 30 mg/kg, approximated to the closest between 2 and 3 grams, of RiaSTAP (King of Prussia, PA, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective cardiac surgery with cardiopulmonary bypass;
- complex cardiac surgery (coronary artery bypass graft + valve repair/replacement; double/triple valve repair/replacement; ascendant aorta surgery);
- written consent to participate;
Key exclusion criteria (7 listed)
- urgent or emergent cardiac surgery;
- known hypersensitivity to the active principle or to one of the excipients of the study drugs;
- coagulation disorders, known or presumable from anamnesis;
- known hepatopathy;
- known risk of thrombosis or disseminated intravascular coagulation;
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 |
|---|---|---|
| FibCLOTAlso: Human Fibrinogen concentrate30 mg/kg of FibCLOT (rounded up to the nearest 2 or 3 grams) after protamine administration | Drug | FibCLOT |
| RiaSTAPAlso: Human Fibrinogen concentrate30 mg/kg of RiaSTAP (rounded up to the nearest 2 or 3 grams) after protamine administration | Drug | RiaSTAP |
Primary outcome
FIBTEM MCF (mm)
Time frame: Within 10 minutes after protamine administration
Fibrinogen contribution to the clot firmness measured by ROTEM device, as maximum clot firmness parameter).
FIBTEM CT and CFT (sec)
Time frame: Within 10 minutes after protamine administration
Fibrinogen contribution to the clot firmness measured by ROTEM device, as time required for clot formation (CT, clotting time, and CFT, clot formation time).
EXTEM CT and CFT (sec)
Time frame: Within 10 minutes after protamine administration
Time required for the overall clot formation on the extrinsic pathway of coagulation ( CT, clotting time, and CFT, clot formation time).
3 secondary outcomes
Postoperative bleeding
Time frame: 12 and 24 hours after surgery
Incidence of moderate/severe bleeding
Time frame: 12 hours after surgery
Incidence of transfusion
Time frame: 12 and 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 26893405Ranucci M, Baryshnikova E. Fibrinogen supplementation after cardiac surgery: insights from the Zero-Plasma trial (ZEPLAST). Br J Anaesth. 2016 May;116(5):618-23. doi: 10.1093/bja/aev539. Epub 2016 Feb 17.
- Background: PubMed 34368944Stolt H, Shams Hakimi C, Singh S, Jeppsson A, Karlsson M. A comparison of the in vitro effects of three fibrinogen concentrates on clot strength in blood samples from cardiac surgery patients. Acta Anaesthesiol Scand. 2021 Nov;65(10):1439-1446. doi: 10.1111/aas.13967. Epub 2021 Sep 1.
- Background: PubMed 30711263Scolletta S, Simioni P, Campagnolo V, Celiento M, Fontanari P, Guadagnucci A, Guarracino F, Haxhiademi D, Paniccia R, Simeone F, Ranucci M; Granducato Research Group. Patient blood management in cardiac surgery: The "Granducato algorithm". Int J Cardiol. 2019 Aug 15;289:37-42. doi: 10.1016/j.ijcard.2019.01.025. Epub 2019 Jan 11.
- Background: PubMed 34217578Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Cardiothorac Vasc Anesth. 2021 Sep;35(9):2569-2591. doi: 10.1053/j.jvca.2021.03.011. Epub 2021 Jun 30. No abstract available.
- Background: PubMed 24332097Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9.
- Derived from this study: PubMed 39383100Baryshnikova E, Aloisio T, Di Dedda U, Anguissola M, Barbaria A, Caravella G, Ranucci M. A Randomized Controlled Trial Comparing Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness. Anesth Analg. 2025 Apr 1;140(4):966-973. doi: 10.1213/ANE.0000000000007201. Epub 2024 Oct 9.
- Individual participant dataSharing planned: No
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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.
Marco Ranucci, MD principal investigator
IRCCS Policlinico S. Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FibCLOT and RiaSTAP in people with Hypofibrinogenemia and Surgical Blood Loss, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIBTEM MCF (mm) (time frame: Within 10 minutes after protamine administration). The study lists 3 primary outcomes in all. 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 NCT05780125, which also lists 6 linked publications.
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 28 Feb 2024.