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Trial record 38 of 458 for:    Inherited Bleeding Disorder

RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery (RiaCT)

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ClinicalTrials.gov Identifier: NCT01283321
Recruitment Status : Terminated (Insufficient funding to complete total projected enrollment)
First Posted : January 25, 2011
Results First Posted : February 16, 2015
Last Update Posted : June 21, 2018
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Gautam Sreeram, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Valve Disease
Coronary Artery Disease
Interventions Drug: Human fibrinogen concentrate
Other: apheresis platelets
Enrollment 26
Recruitment Details Enrollment started in February 2011 and the study was completed in May 2012. Subjects were recruited from Emory University. Fifty-one patients were approached after initial screening for eligibility, and 26 patients were consented.
Pre-assignment Details Two subjects were excluded due to a change in surgical plans. Two subjects had low bleeding scores and were excluded.One subject had screening labs that were out of range for the study. One subject was treated using Dabigatran treatment. Total of six subjects that were excluded prior to randomization.
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets
Hide Arm/Group Description Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets Total
Hide Arm/Group Description

Human fibrinogen concentrate

Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding

single apheresis unit

apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
20 subjects were randomized after the screening visit/labs
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
2
  20.0%
2
  10.0%
>=65 years
10
 100.0%
8
  80.0%
18
  90.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
71.3  (5.3) 66.1  (8.9) 68.7  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
2
  20.0%
2
  20.0%
4
  20.0%
Male
8
  80.0%
8
  80.0%
16
  80.0%
1.Primary Outcome
Title Bleeding Scores
Hide Description Bleeding scores are scored on a four-point scale. A visual assessment of surgical field was performed by the senior surgical staff as follows: 0 = excellent hemostasis (dry field), 1 = mild bleeding (oozing), 2 = moderate bleeding (controllable with applied pressure), and 3 = severe bleeding (multiple diffuse bleeding sites). If the visual bleeding scale was 2 to 3, the subjects were randomly assigned to a study intervention using a closed envelope method.
Time Frame intra-operatively and up to 24 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets
Hide Arm/Group Description:

Human fibrinogen concentrate

Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding

single apheresis unit

apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Intraoperative 2.0  (0.0) 2.1  (0.3)
Postoperative 1.0  (0.7) 1.7  (0.8)
2.Secondary Outcome
Title Number of Participants in Whom Transfusion of Platelet Concentrate is Required During or After Surgery.
Hide Description [Not Specified]
Time Frame Operative period up to 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets
Hide Arm/Group Description:
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
4
  40.0%
10
 100.0%
3.Secondary Outcome
Title Volume (mL) of Fresh-frozen Plasma (FFP) Transfused-during Surgery and up to 24 Hours After Surgery
Hide Description [Not Specified]
Time Frame Operative period up to 60 minutes and up to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets
Hide Arm/Group Description:
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: ml
0
(0 to 1300)
650
(0 to 1300)
4.Secondary Outcome
Title Volume (mL) of Platelets Transfused- During Surgery and up to 24 Hours After Surgery
Hide Description [Not Specified]
Time Frame Operative period up to 60 minutes and up to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets
Hide Arm/Group Description:
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: ml
0
(0 to 750)
500
(250 to 1000)
5.Secondary Outcome
Title Median Blood Loss (mL) at 12 Hours After Surgery
Hide Description [Not Specified]
Time Frame From end of surgery to 12 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets
Hide Arm/Group Description:
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: ml
925
(500 to 1693)
1315
(653 to 2965)
Time Frame Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A: RiaSTAP Group B: Apheresis Platelets
Hide Arm/Group Description

Human fibrinogen concentrate

Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding

single apheresis unit

apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.

All-Cause Mortality
Group A: RiaSTAP Group B: Apheresis Platelets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A: RiaSTAP Group B: Apheresis Platelets
Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   6/10 (60.00%) 
Cardiac disorders     
Atrial Fibrillation *  0/10 (0.00%)  2/10 (20.00%) 
Acute myocardial infarction *  0/10 (0.00%)  1/10 (10.00%) 
Injury, poisoning and procedural complications     
Excessive mediastinal bleeding *  1/10 (10.00%)  3/10 (30.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A: RiaSTAP Group B: Apheresis Platelets
Affected / at Risk (%) Affected / at Risk (%)
Total   3/10 (30.00%)   5/10 (50.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema *  3/10 (30.00%)  5/10 (50.00%) 
*
Indicates events were collected by non-systematic assessment
Early termination leading to small number of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kenichi Tanaka
Organization: University of Maryland
Phone: 412-328-0205
EMail: ktanaka@anes.umm.edu
Layout table for additonal information
Responsible Party: Gautam Sreeram, Emory University
ClinicalTrials.gov Identifier: NCT01283321     History of Changes
Other Study ID Numbers: IRB00036062
RiaCT 2010 ( Other Identifier: Other )
First Submitted: January 24, 2011
First Posted: January 25, 2011
Results First Submitted: January 20, 2015
Results First Posted: February 16, 2015
Last Update Posted: June 21, 2018