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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2500 |
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Date of registration:
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09/09/2010 |
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Primary sponsor: |
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Public title:
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The use of Fibrin Sealant in total knee replacement surgery.
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Scientific title:
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The use of Fibrin Sealant in total knee replacement surgery. - Cryoseal in TKR |
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Date of first enrolment:
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1/1/2011 |
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Target sample size:
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500 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2500 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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W.Chr.
Verra |
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Address:
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PO Box 9600, Postzone J-11-R, Leiden University Medical Center
Department of orthopaedic surgery
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5261566 |
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Email:
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w.c.verra@lumc.nl |
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Affiliation:
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Name:
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W.Chr.
Verra |
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Address:
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PO Box 9600, Postzone J-11-R, Leiden University Medical Center
Department of orthopaedic surgery
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5261566 |
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Email:
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w.c.verra@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients who will undergo primary total knee replacement surgery for osteoarthritis or rheumatic arthritis;
2. Age, minimum of 18 years;
3. (Admission of the patient after informed consent);
4. ASA classification I-III.
Exclusion criteria: 1. Liver failure;
2. Congenital or acquired coagulation disorders;
3. Patients with known haemophilia or von Willibrand disease;
4. Patients with INR >2 (standard practice for operation).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Total knee replacement (TKR), Rehabilitation, Fibrin sealant
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Intervention(s)
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The CryoSeal (CS) experimental product consists of two components: cryoprecipitate and thrombin. Cryoprecipitate is one fraction of a single human plasma donation that contains concentrated coagulation factors, such as fibrinogen, which together with the second fraction containing an enzyme thrombin, that facilitating the conversion of fibrinogen into fibrin. Together mixed they will form a clot. This product has two main advantages compared to other current available preparations, namely a single donor-exposure compared to commercial allogeneic fibrin Sealant (FS) products, produced from pooled multiple plasma donations which also has a bovine thrombin source and secondly the controlled hemostatic conditions of the product compared to autologous FS, prepared prior to surgery or at the operation theatre and which content is dependent on its hemostatic condition of patients (age, co-morbidity Based on preliminary estimations on CS use in the literature (1), 12-15 ml CS is expected to be used per patient randomized for CS.
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Primary Outcome(s)
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Postoperative knee function in mean extension difference with goniometric at 2 and 6 weeks (in relation to secondary endpoints), corrected for pre-operative extension.
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Secondary Outcome(s)
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1. Postoperative Hb/Ht;
2. Number of transfusions after surgery;
3. VAS pain score;
4. Complications;
5. Total hospital stay and duration of rehabilitation;
6. Illness perception IPQ-K score;
7. Function improvement score (KSS, Barthel Index score, KOOS);
8. Postoperative F/E.
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Source(s) of Monetary Support
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Sanquin Blood Supply
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