Clinical trial NCT01124981: Haemocomplettan® P During Elective Complex Cardiac Surgery
Official title: Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fibrinogen Deficiency in Complex Cardiac Surgery
Keywords: Fibrinogen concentrate
Coagulopathy
Lead sponsor: Isala
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2010-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older.
* Undergoing elective complex cardiac surgery.
* Understood and willingly given written informed consent.
* Experience clinically relevant non-surgical microvascular bleeding following removal of cardiopulmonary bypass.

Exclusion Criteria:

* Positive pregnancy test, pregnancy or lactation.
* Undergoing an emergency operation.
* Proof or suspicion of a congenital or acquired coagulation disorder.
* Clopidogrel use in the 5 days preceding surgery.
* INR \>1.4 if on coumadin.

Primary outcomes:
measure: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss.
timeFrame: within 12 hours.
Secondary outcomes:
measure: To determine whether fibrinogen concentrate infusion reduces postoperative blood loss.
timeFrame: within 24 hours after infusion of study medication.
measure: To determine whether fibrinogen concentrate infusion reduces postoperative transfusion of blood products during elective complex cardiac surgery.
timeFrame: within 24 hours after infusion of study medication.
measure: To determine whether fibrinogen concentrate infusion is safe and well-tolerated.
timeFrame: 30 days
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Department Anesthesiology & Intensive Care
state: Overijssel
city: Zwolle
country: Netherlands
facility: Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken
state: Overijssel
Study officials:
affiliation: Isala
name: Arno P Nierich, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bilecen S, de Groot JA, Kalkman CJ, Spanjersberg AJ, Brandon Bravo Bruinsma GJ, Moons KG, Nierich AP. Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery: A Randomized Clinical Trial. JAMA. 2017 Feb 21;317(7):738-747. doi: 10.1001/jama.2016.21037.