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A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00194987
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
New York Presbyterian Hospital
Columbia University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief Summary:
The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).

Condition or disease Intervention/treatment Phase
Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia Drug: IVIG (Intravenous Immunoglobulin) Drug: prednisone Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomization between 2 groups
Masking: None (Open Label)
Masking Description: participants and their physicians will know if they are receiving IVIG x 2 or IVIG x1 plus prednisone
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Study Start Date : April 2001
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arms and Interventions
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Arm Intervention/treatment
Experimental: IVIG x 2
IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT
 Drug: IVIG (Intravenous Immunoglobulin)
one gram per kg of IVIG per infusion given either once or twice
Experimental: IVIG x 1 + prednisone
IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT
 Drug: IVIG (Intravenous Immunoglobulin)
one gram per kg of IVIG per infusion given either once or twice

Drug: prednisone
in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day


Outcome Measures
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Primary Outcome Measures :
  1. Number of Newborns With a Birth Platelet Count > 50,000/uL [ Time Frame: 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40 ]
    this uses the birth platelet count of the fetuses from the study when they are born


Secondary Outcome Measures :
  1. Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study [ Time Frame: time of ICH (range 20-40 wks) ]
    number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation

  2. Number of Fetal Platelet Counts > 50,000/uL [ Time Frame: 32 +/- 2 weeks ]
    Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pregnant women are eligible for inclusion into the Very High Risk Group if they:

  • are PLA-1 (platelet antigen A1) negative and have known platelet incompatibility with their fetus
  • have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated)
  • are less than 19 weeks gestation

Pregnant women are eligible for inclusion into the High Risk Group if they:

  • are PLA-1 negative and have known platelet incompatibility with the fetus
  • have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated)
  • are between 12-30 weeks gestation

Pregnant women are eligible for inclusion into the Standard Risk Group if they:

  • are PLA-1 negative and have known platelet incompatibility with the fetus
  • have not had a previous child who suffered an antenatal hemorrhage
  • are between 20-30 weeks gestation

Exclusion Criteria:

Women are not eligible for inclusion into the Very High Risk Group if they:

  • have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
  • are greater than 19 weeks gestation

Women are not eligible for inclusion into the High Risk Group if they:

  • have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
  • are greater than 30 weeks gestation

Women are not eligible for inclusion into the Standard Risk Group if they:

  • have had a previous child who suffered an antenatal hemorrhage
  • are greater than 30 weeks gestation
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00194987


Locations
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United States, New York
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
Columbia University
Investigators
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Principal Investigator: James B Bussel, M.D. Weill Medical College of Cornell University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00194987    
Other Study ID Numbers: 0102004801
First Posted: September 19, 2005    Key Record Dates
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018
Last Verified: October 2018
Keywords provided by Weill Medical College of Cornell University:
Alloimmune thrombocytopenia
Fetal alloimmune thrombocytopenia
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Prednisone
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors