Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780125
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-02-22
Brief Title:
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
Sponsor:
IRCCS Policlinico S Donato
Organization:
IRCCS Policlinico S Donato
Study Overview
Official Title:
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EDIPORE
Brief 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 15-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
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 11 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 mgkg 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 mlmin 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 100000 cellsµL
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 15
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
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 11 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 mgkg 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 mlmin 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 100000 cellsµL
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 15
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None