Haemocomplettan® P During Elective Complex Cardiac Surgery

Phase 2

Completed

• Conditions: Fibrinogen Deficiency in Complex Cardiac Surgery
• Interventions: Drug: Human albumin (Placebo); Drug: Haemocomplettan® P

• Registration Number: NCT01124981
• Lead Sponsor: Isala

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.

Study Timeline

• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Study Start: 2011-02
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin	Human albumin (Placebo)	-
Haemocomplettan® P	Haemocomplettan® P	-

Primary Outcome Measures

Name	Time	Method
To determine whether fibrinogen concentrate infusion reduces perioperative blood loss.	within 12 hours.	Perioperative blood loss measured as blood loss in ml between infusion of study medication and closure of chest.

Secondary Outcome Measures

Name	Time	Method
To determine whether fibrinogen concentrate infusion reduces postoperative blood loss.	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.	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.	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

Trial Locations

Locations (2)

Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken; 🇳🇱 Zwolle, Overijssel, Netherlands

Department Anesthesiology & Intensive Care; 🇳🇱 Zwolle, Overijssel, Netherlands