The Association Between Platelet Reactivity and Bleeding Risk in Adult ITP

NCT03377439 | Unknown DMC

• 1 other identifier: Plt function and bleeding risk
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

It seems reasonable to assume that patients who present significant bleeding symptoms may have different quality of platelets than those without bleeding. This question was addressed in a study that examined platelet function in adult ITP patients, which try to determine whether this correlated with bleeding risk. Previous reports have suggested that measuring platelet function may help define patients at highest risk of bleeding. In addition, Middelburg and colleagues corrected platelet function for quartile of platelet count, using \<32×10\^9/L as the lowest cohort and \>132×10\^9/L as the top quartile. They demonstrated that increased platelet reactivity (as measured by flow cytometry) was associated with decreased risk of bleeding but particularly for those patients with the lowest platelet counts. Further studies in a larger cohort are needed to confirm this correlation. Our study aimed at standardizing a prediction model to evaluate the bleeding risk of adult ITP patients with the use of platelet function tests.

Conditions

Immune Thrombocytopenia

Keywords

Platelet function; Bleeding risk; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• The severity of bleeding manifestations at onset was assessed using a previously described clinical scoring system with minor modifications. The total bleeding score was calculated by adding the scores for each item.

  The bleeding score system: 1) Age: Age over 65 years (2'); Age over 75 years (5'). 2) Cutaneous bleeding: Localized petechial purpura (1'); Localized ecchymotic purpura (2'); Two locations of petechial purpura (2'); Generalized petechial purpura (3'); Generalized ecchymotic purpura (4'). 3) Mucosal bleeding: Unilateral epistaxis (2'); Bilateral epistaxis (3'); Hemorrhagic oral bullae and/or gingival bleeding (5'). 4) Gastrointestinal bleeding: Gastrointestinal hemorrhage without anemia (4'); Gastrointestinal hemorrhage with acute anemia and/or shock (15'). 5) Urinary bleeding: Macroscopic hematuria without anemia (4'); Macroscopic hematuria with acute anemia (10'). 6) Genitourinary tract bleeding: Major meno/metrorrhagia without anemia (4'); Major meno/metrorrhagia with acute anemia (10'). 7) Central nervous system bleeding: Central nervous system bleeding and/or life-threatening hemorrhage (15').

  No more than three months after platelet function assessment.

Study Arms (3)

Group A

Participants with platelet counts \<32×10\^9/L.

Other: Platelet function tests

Group B

Participants with platelet counts between 32×10\^9/L and 132×10\^9/L.

Other: Platelet function tests

Group C

Participants with platelet counts \>132×10\^9/L.

Other: Platelet function tests

Interventions

Platelet function tests OTHER

Platelet reactivity was measured by flow cytometry, filopodia detection and the platelet aggregation analyzer.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Untreated adult ITP patients of both genders between the ages of 18 and 80 years.

You may qualify if:

• Untreated adult ITP patients of both genders between the ages of 18 and 80 years.
• Participants of either acute or chronic phase; with or without thrombocytopenia; with or without bleeding manifestation.

You may not qualify if:

• Received high-dose steroids or IVIG within 3 weeks prior to the test.
• Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months prior to the test.
• Current HIV infection, hepatitis B virus or hepatitis C virus infections.
• Severe medical condition (liver and kidney function impairment).

Sponsors & Collaborators

• Shandong University: lead
• Traditional Chinese Medicine Hospital Affiliated to Shandong University: collaborator
• Jinan Central Hospital: collaborator
• Qianfoshan Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Shandong University Second Hospital: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (7)

• Khellaf M, Michel M, Schaeffer A, Bierling P, Godeau B. Assessment of a therapeutic strategy for adults with severe autoimmune thrombocytopenic purpura based on a bleeding score rather than platelet count. Haematologica. 2005 Jun;90(6):829-32.

  PMID: 15951296 BACKGROUND

• Middelburg RA, Roest M, Ham J, Coccoris M, Zwaginga JJ, van der Meer PF. Flow cytometric assessment of agonist-induced P-selectin expression as a measure of platelet quality in stored platelet concentrates. Transfusion. 2013 Aug;53(8):1780-7. doi: 10.1111/trf.12001. Epub 2012 Dec 7.

  PMID: 23216254 BACKGROUND

• Middelburg RA, Carbaat-Ham JC, Hesam H, Ragusi MA, Zwaginga JJ. Platelet function in adult ITP patients can be either increased or decreased, compared to healthy controls, and is associated with bleeding risk. Hematology. 2016 Oct;21(9):549-51. doi: 10.1080/10245332.2016.1180097. Epub 2016 May 9.

  PMID: 27159138 BACKGROUND

• Panzer S, Hocker L, Koren D. Agonists-induced platelet activation varies considerably in healthy male individuals: studies by flow cytometry. Ann Hematol. 2006 Feb;85(2):121-5. doi: 10.1007/s00277-005-0029-5. Epub 2005 Nov 10.

  PMID: 16283308 BACKGROUND

• Panzer S, Rieger M, Vormittag R, Eichelberger B, Dunkler D, Pabinger I. Platelet function to estimate the bleeding risk in autoimmune thrombocytopenia. Eur J Clin Invest. 2007 Oct;37(10):814-9. doi: 10.1111/j.1365-2362.2007.01855.x. Epub 2007 Aug 28.

  PMID: 17727674 BACKGROUND

• Mangin P, Yuan Y, Goncalves I, Eckly A, Freund M, Cazenave JP, Gachet C, Jackson SP, Lanza F. Signaling role for phospholipase C gamma 2 in platelet glycoprotein Ib alpha calcium flux and cytoskeletal reorganization. Involvement of a pathway distinct from FcR gamma chain and Fc gamma RIIA. J Biol Chem. 2003 Aug 29;278(35):32880-91. doi: 10.1074/jbc.M302333200. Epub 2003 Jun 17.

  PMID: 12813055 BACKGROUND

• Maurer E, Tang C, Schaff M, Bourdon C, Receveur N, Ravanat C, Eckly A, Hechler B, Gachet C, Lanza F, Mangin PH. Targeting platelet GPIbbeta reduces platelet adhesion, GPIb signaling and thrombin generation and prevents arterial thrombosis. Arterioscler Thromb Vasc Biol. 2013 Jun;33(6):1221-9. doi: 10.1161/ATVBAHA.112.301013. Epub 2013 Apr 4.

  PMID: 23559635 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Platelet Function Tests

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jun Peng, MD, PhD

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Ming Hou Hou, MD, PhD

CONTACT

86-531-82169879; qlhouming@sina.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 19, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

CN (1)