Haemocomplettan® P During Elective Complex Cardiac Surgery
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ClinicalTrials.gov Identifier: NCT01124981 |
Recruitment Status :
Completed
First Posted : May 18, 2010
Last Update Posted : December 16, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibrinogen Deficiency in Complex Cardiac Surgery | Drug: Haemocomplettan® P Drug: Human albumin (Placebo) | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
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 |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124981
Netherlands | |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Arno P. Nierich, MD, PhD, Isala |
ClinicalTrials.gov Identifier: | NCT01124981 |
Other Study ID Numbers: |
BI1401_2010 |
First Posted: | May 18, 2010 Key Record Dates |
Last Update Posted: | December 16, 2014 |
Last Verified: | December 2014 |
Fibrinogen concentrate Coagulopathy |
Afibrinogenemia Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |