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Protamine in Cardiac Surgery and Haemostasis (PROTT)

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ClinicalTrials.gov Identifier: NCT01608971
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : November 20, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Andreas Koster, Heart and Diabetes Center North-Rhine Westfalia

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Bleeding
Hemorrhage
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Heparin Level Based Protamine Group Weight Based Protamine Group
Hide Arm/Group Description In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass. In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Weight Based Protamine Group Heparin Level Based Protamine Group Total
Hide Arm/Group Description In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg) In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  26.7%
3
  20.0%
7
  23.3%
>=65 years
11
  73.3%
12
  80.0%
23
  76.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
5
  33.3%
9
  60.0%
14
  46.7%
Male
10
  66.7%
6
  40.0%
16
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer
Hide Description The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT [seconds](coagulation time), CFT [seconds] (clot formation time) and the CT [seconds] of the HEPTEM test which is non sensitive for residual heparine.
Time Frame Tests will be measured 15 minutes after Protamine infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Rotem INTEM CT, CFT, MCF and FIBTEM MCF and Heptem CT
Arm/Group Title Heparin Level Based Protamine Group Weight Based Protamine Group
Hide Arm/Group Description:
In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Overall Number of Participants Analyzed 15 15
Median (Inter-Quartile Range)
Unit of Measure: seconds
CFT Intem
98
(78 to 131)
117
(103 to 170)
CT Intem
178
(163 to 199)
253
(202 to 371)
CT Heptem
185
(169 to 201)
267
(209 to 333)
2.Primary Outcome
Title Rotem MCF Fibtem and MCF Intem
Hide Description The following parameters of the INTEM test will be analyzed: MCF [mm] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF [mm] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.
Time Frame 15 Minutes after protamine infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Patients of both groups
Arm/Group Title Heparin Level Based Protamine Group Weight Based Protamine Group
Hide Arm/Group Description:
In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Overall Number of Participants Analyzed 15 15
Median (Inter-Quartile Range)
Unit of Measure: mm
MCF Intem
55
(51 to 60)
57
(53 to 63)
MCF Fibtem
9
(7 to 14)
13
(10 to 15)
3.Secondary Outcome
Title Transfusion of Blood Products and Coagulation Factors
Hide Description The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .
Time Frame From protamine administration until 12 h after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Transfusion of RBC
Arm/Group Title Weight Based Protamine Group Heparin Level Based Protamine Group
Hide Arm/Group Description:
In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: percentage of patients transfused
RBC transfusion 76.7 80
PCC transfusion 20 60
FFP transfusiom 20 60
RDPC transfusion 7 15
Fibrinogen transfusion 33.3 20
4.Secondary Outcome
Title 12 h Postoperative Blood Loss
Hide Description The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.
Time Frame 15 min after protamine administration until 12 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Weight Based Protamine Group Heparin Level Based Protamine Group
Hide Arm/Group Description:
In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
Overall Number of Participants Analyzed 15 15
Median (Inter-Quartile Range)
Unit of Measure: ml/12 hour
620
(600 to 700)
723
(600 to 850)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Heparin Level Based Protamine Group Weight Based Protamine Group
Hide Arm/Group Description In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass. In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
All-Cause Mortality
Heparin Level Based Protamine Group Weight Based Protamine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Heparin Level Based Protamine Group Weight Based Protamine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Blood and lymphatic system disorders     
Excessive bleeding   0/15 (0.00%)  0 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Heparin Level Based Protamine Group Weight Based Protamine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andreas Koster
Organization: Heart and Diabetes Center NRW
Phone: 0043 5731 3284
EMail: akoster@hdz-nrw.de
Layout table for additonal information
Responsible Party: Andreas Koster, Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01608971     History of Changes
Other Study ID Numbers: 007
First Submitted: May 29, 2012
First Posted: May 31, 2012
Results First Submitted: March 17, 2015
Results First Posted: November 20, 2015
Last Update Posted: March 27, 2017