Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia

Thrombocytopenia Clinical Trial

— MICE  

Official title:

Experimental Protocol for the Infusion of Platelets,Cryopreserved With Dimethyl Sulphoxide (DMSO) and Obtained From Multiple Donors Buffy Coats, in Patients With Severe Thrombocytopenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02032134
• Other study ID #: CUP: G33F1100003000
• Status: Terminated
• Phase: Phase 4
• First received: January 7, 2014
• Last updated: October 17, 2017
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2017
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The increasing need for blood components and the increasingly careful donor selection procedures, make the availability of blood components very reduced, in particular for platelets that are currently administered preferably "fresh" or cryopreserved, only in emergency conditions.

Exceeding this limit through the spread of use of cryopreserved platelets in the common clinical practice, might help clinicians to avoid wasting valuable products and face periods of particular shortage of donors Some studies already published in the literature over the last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved platelets .

The main objective of the proposed study is to evaluate the efficacy and safety of platelets, cryopreserved with DMSO using a a new method, in patients with severe thrombocytopenia.

This is the in vivo phase of a study where availability and efficacy of cryopreserved platelets has been assessed in vitro.

Description:

The primary objective of the study is to evaluate the hemostatic efficacy and safety in the recipients of platelets obtained from buffy coat of multiple donors (five), cryopreserved with DMSO using a new patented method, up to 9 months from the collection.

Further goals are the registration of any related- adverse event (idiosyncrasy, allergy, toxicity)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Cryopreserved buffy coat pooled platelets will be infused, after being thawed, in inpatients at U.O. of Hematology -Policlinic "P. Giaccone"-Palermo, falling into one of the following categories:

• Stable clinical conditions and no complications with platelets = 10,000/microliter;

• With active bleeding and = 20,000 platelets/microliter;

• In the presence of: high blood pressure, high fever, rapid drop in platelets, infection, chemotherapy, coagulation abnormalities with = 20,000 platelets/microliter.

Exclusion Criteria:

Patients

• Suffering from congenital immunodeficiency

• Allogeneic bone marrow transplant candidates

• Bone Marrow Donors for transplantation

• Undergoing bone marrow transplant or

• Suffering from Hodgkin's disease and treated with purine analogues (Fludarabine, cladribine)

Related Conditions & MeSH terms

• Primary Thrombocytopenia,Unspecified
• Thrombocytopenia
• Thrombocytopenia Chemotherapy Induced

Intervention

Biological:
• Transfusion of Pooled Platelets Cryopreserved In DMSO
Patients with severe thrombocytopenia will be admitted as in patients at the Hematology Unit of the Policlinic "P. Giaccone"- Palermo, if they require platelet transfusion (for bleeding, in preparation for surgery, after chemotherapy); they will receive buffy coat derived cryopreserved platelets,after thawing

Locations

Country	Name	City	State
Italy	AOUP "P.Giaccone"-Hematology Unit	Palermo	Regione Sicilia

Sponsors (2)

Lead Sponsor	Collaborator
Napolitano Mariasanta	Regione Sicilia

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Dumont LJ, Cancelas JA, Dumont DF, Siegel AH, Szczepiorkowski ZM, Rugg N, Pratt PG, Worsham DN, Hartman EL, Dunn SK, O'Leary M, Ransom JH, Michael RA, Macdonald VW. A randomized controlled trial evaluating recovery and survival of 6% dimethyl sulfoxide-frozen autologous platelets in healthy volunteers. Transfusion. 2013 Jan;53(1):128-37. doi: 10.1111/j.1537-2995.2012.03735.x. Epub 2012 Jun 7. — View Citation

Dumont LJ, Dumont DF, Unger ZM, Siegel A, Szczepiorkowski ZM, Corson JS, Jones MK, Christoffel T, Pellham E, Bailey SL, Slichter SJ; BEST Collaborative. A randomized controlled trial comparing autologous radiolabeled in vivo platelet (PLT) recoveries and survivals of 7-day-stored PLT-rich plasma and buffy coat PLTs from the same subjects. Transfusion. 2011 Jun;51(6):1241-8. doi: 10.1111/j.1537-2995.2010.03007.x. Epub 2011 Jan 7. — View Citation

Heal JM, Blumberg N. Optimizing platelet transfusion therapy. Blood Rev. 2004 Sep;18(3):149-65. Review. — View Citation

Liu GQ, Ding HF, Lu XJ, Xu M, Xing J, Zhao X, Han F, Shang YH. [The efficacy and safety of autologous cryopreserved platelet transfusion in management of thrombocytopenia after chemotherapy in hematological malignancy]. Zhonghua Nei Ke Za Zhi. 2012 Mar;51(3):188-91. Chinese. — View Citation

Meyer E, Delaney M, Lin Y, Morris A, Pavenski K, Tinmouth A, Murphy M, Slichter SJ, Heddle N, Dumont LJ. A reporting guideline for clinical platelet transfusion studies from the BEST Collaborative. Transfusion. 2013 Jun;53(6):1328-34. doi: 10.1111/j.1537-2995.2012.03906.x. Epub 2012 Sep 25. — View Citation

Murphy MF, Brozovic B, Murphy W, Ouwehand W, Waters AH. Guidelines for platelet transfusions. British Committee for Standards in Haematology, Working Party of the Blood Transfusion Task Force. Transfus Med. 1992 Dec;2(4):311-8. — View Citation

Wautier JL. Safety and usefulness of autologous cryopreserved platelets. Lancet. 2002 Dec 14;360(9349):1985. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion)	To evaluate the availability of cryopreserved platelets after transfusion, the correct count (the number of platelets poured and the body surface, BMI, recipient) of platelets will be determined at 1 hour and 24 hours post transfusion, respectively	1 Hour and 24 hours post-transfusion
Secondary	Safety of cryopreserved platelets	Any transfusion-related side effect (i.e. idiosyncrasy, allergy, toxicity) will be monitored	During transfusion and within 48 hours after transfusion

External Links

•   Abstract from ASH Annual Meeting 2013. Poster 1158 refers to in vitro results related to the current proposed clinical trial