Trial record 4 of 4 for:
"Afibrinogenemia"
Haemocomplettan® P During Elective Complex Cardiac Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Isala Klinieken.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Isala Klinieken
Information provided by:
Isala Klinieken
ClinicalTrials.gov Identifier:
NCT01124981
First received: May 10, 2010
Last updated: June 7, 2011
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibrinogen Deficiency in Complex Cardiac Surgery |
Drug: Haemocomplettan® P Drug: Human albumin (Placebo) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Isala Klinieken:
Primary Outcome Measures:
- To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. [ Time Frame: within 12 hours. ] [ Designated as safety issue: No ]Perioperative blood loss measured as blood loss in ml between infusion of study medication and closure of chest.
Secondary Outcome Measures:
- To determine whether fibrinogen concentrate infusion reduces postoperative blood loss. [ Time Frame: within 24 hours after infusion of study medication. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124981
Contacts
| Contact: Marga Hoogendoorn, Msc. | 003138 424 4245 | m.e.hoogendoorn@isala.nl |
Locations
| Netherlands | |
| Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken | Not yet recruiting |
| Zwolle, Overijssel, Netherlands, 8011 JW | |
| Contact: Marga E Hoogendoorn, Msc. 003138 424 4245 m.e.hoogendoorn@isala.nl | |
| Department Anesthesiology & Intensive Care | Recruiting |
| Zwolle, Overijssel, Netherlands, 8011 JW | |
| Contact: Marga Hoogendoorn, Drs. +31-38-4244245 m.e.hoogendoorn@isala.nl | |
Sponsors and Collaborators
Isala Klinieken
Investigators
| Principal Investigator: | Arno P Nierich, MD, PhD. | Isala Klinieken Zwolle |
More Information
Additional Information:
No publications provided
| Responsible Party: | Arno P. Nierich, MD, PhD, Department of Cardiothoracic Anaesthesia and Intensive Care Isala Clinics Zwolle. The Netherlands. |
| ClinicalTrials.gov Identifier: | NCT01124981 History of Changes |
| Other Study ID Numbers: | BI1401_2010 |
| Study First Received: | May 10, 2010 |
| Last Updated: | June 7, 2011 |
| Health Authority: | The Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO). METC Zwolle. |
Keywords provided by Isala Klinieken:
|
Fibrinogen concentrate Coagulopathy |
Additional relevant MeSH terms:
|
Afibrinogenemia Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 16, 2013