Skip to main content
OpenTrials
Completed

NCT Number: NCT01124981

Haemocomplettan® P During Elective Complex Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibrinogen Deficiency in Complex Cardiac Surgery Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department Anesthesiology & Intensive Care, Zwolle, Overijssel, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haemocomplettan® P

Drug

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 names: Fibrinogen concentrate

Human albumin (Placebo)

Drug

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 names: Albumin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Isala

Other

Collaborators

  • CSL Behring

Registry information

Official study title

Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 18, 2010
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.