Haemocomplettan® P During Elective Complex Cardiac Surgery
|Fibrinogen Deficiency in Complex Cardiac Surgery||Drug: Haemocomplettan® P Drug: Human albumin (Placebo)||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery|
- To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. [ Time Frame: within 12 hours. ]Perioperative blood loss measured as blood loss in ml between infusion of study medication and closure of chest.
- To determine whether fibrinogen concentrate infusion reduces postoperative blood loss. [ Time Frame: within 24 hours after infusion of study medication. ]Postoperative blood loss, measured as blood loss at the ICU between closure of chest and 1st hour, 6th hour and after 24 hours.
- To determine whether fibrinogen concentrate infusion reduces postoperative transfusion of blood products during elective complex cardiac surgery. [ Time Frame: within 24 hours after infusion of study medication. ]Number of units red blood cell concentrate, fresh frozen plasma and platelet concentrate administered within 24 hours after closure of chest.
- To determine whether fibrinogen concentrate infusion is safe and well-tolerated. [ Time Frame: 30 days ]Major clinical events: Mortality at 30 days post-surgery, MACE (major adverse cardiac event), cerebrovascular accident/ transient ischemic attack, renal insufficiency or failure, venous thromboembolism/ pulmonary embolism, allergic or other systemic reaction to study medication
|Study Start Date:||February 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Albumin||
Drug: Human albumin (Placebo)
Human albumin with concentration 200g/L. The study bottles of 50 mL will be diluted with saline and will contain 2g in total. This concentration resembles the total protein load in the bottles with Haemocomplettan® P.
Other Name: Albumin
|Experimental: Haemocomplettan® P||
Drug: Haemocomplettan® P
Dosing of study medication will be individually determined based on plasma fibrinogen concentrations (measured with Clauss method during the reperfusion period on CPB) and body weight. Intravenous infusion within 10 minutes.
Other Name: Fibrinogen concentrate
Fibrinogen concentrate is increasingly used in surgical patients suffering excessive bleeding refractory to conventional hemostasis treatment. However, these studies published so far comprise small study groups with questionable study designs.
The aim of this study is to determine whether fibrinogen concentrate reduces blood loss and transfusion in patients undergoing elective complex cardiac surgery.
By choosing the domain of complex cardiac surgery which is prone for excessive blood loss and transfusion, we will focus on subjects undergoing high risk procedures. Hereby we hypothesize that administration of fibrinogen concentrate improves hemostasis in patients experiencing microvascular bleeding during complex cardiac surgery. This improvement of the hemostasis is measured by reduced blood loss and transfusion of blood products during surgery and the postoperative period.
Furthermore, we hypothesize that fibrinogen concentrate is safe and well tolerated in patients undergoing complex cardiac surgery. This hypothesis will be investigated by a detailed study of clinical outcomes.
Update regarding interim-analysis:
On 09 August 2013 an interim-analysis was performed as described in the protocol. The outcome was discussed during the Steering Committe of 09 October 2013. During that meeting, based on the results of the interim-analysis, the continuation of the current study was ordered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124981
|Department Anesthesiology & Intensive Care|
|Zwolle, Overijssel, Netherlands, 8011 JW|
|Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken|
|Zwolle, Overijssel, Netherlands, 8011 JW|
|Principal Investigator:||Arno P Nierich, MD, PhD.||Isala Klinieken, Zwolle|