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Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery

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ClinicalTrials.gov Identifier: NCT02311309
Recruitment Status : Completed
First Posted : December 8, 2014
Results First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Surgery
Blood Loss
Interventions Other: Control
Other: Unanticipated bleeding
Enrollment 1439
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Unanticipated Bleeding No Significant Bleeding
Hide Arm/Group Description

Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.

Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL.

Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.

Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.

Patients in whom surgery did not resulted in significant bleeding
Period Title: Overall Study
Started 541 [1] 35 [1] 863
Completed 541 35 863
Not Completed 0 0 0
[1]
There were 863 patients with no peroperative bleeding in the 1439 patients studied
Arm/Group Title Control Unanticipated Bleeding No Peroperative Significant Bleeding Total
Hide Arm/Group Description

Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.

Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL.

Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.

Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.

Patients for whom surgery did not result in significant bleeding Total of all reporting groups
Overall Number of Baseline Participants 541 35 863 1439
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 541 participants 35 participants 863 participants 1439 participants
59  (17) 66  (16) 53  (19) 56  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 541 participants 35 participants 863 participants 1439 participants
Female
254
  47.0%
19
  54.3%
405
  46.9%
678
  47.1%
Male
287
  53.0%
16
  45.7%
458
  53.1%
761
  52.9%
ASA class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 541 participants 35 participants 863 participants 1439 participants
ASA Class 1 107 2 261 370
ASA Class 2 283 18 448 749
ASA Class 3 150 14 150 314
ASA Class 4 1 1 4 6
[1]
Measure Description: ASA class reported in number of patients in a 4 class scale as defined by the American Society of anesthesiologists ASA 1 : otherwise healthy patient ASA 2 : A patient with mild systemic disease ASA 3 : A patient with severe systemic disease ASA 4 : A patient with severe systemic disease that is a constant threat to life
body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 541 participants 35 participants 863 participants 1439 participants
28  (6) 27  (6) 26  (6) 27  (6)
red blood cell pre-planned (yes/no)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 541 participants 35 participants 863 participants 1439 participants
Yes 173 17 28 218
No 368 18 835 1221
Units of packed red blood cell pre planned (number)  
Median (Inter-Quartile Range)
Unit of measure:  Units of packed red blood cell
Number Analyzed 541 participants 35 participants 863 participants 1439 participants
3
(2 to 3)
3
(3 to 4)
2
(2 to 3)
3
(2 to 3)
1.Primary Outcome
Title Unanticipated Bleeding
Hide Description From arrival in operating room until the patients leave post anesthesia care unit
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Unanticipated Bleeding No Significant Bleeding
Hide Arm/Group Description:

Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.

Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL.

Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.

Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.

Patients in whom surgery did not resulted in significant bleeding
Overall Number of Participants Analyzed 541 35 863
Measure Type: Number
Unit of Measure: percentage of participants
0 100 0
2.Secondary Outcome
Title Transfusions
Hide Description transfusion pattern in the whole cohort
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Unanticipated Bleeding No Significant Bleeding
Hide Arm/Group Description:

Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.

Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL.

Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.

Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.

Patients in whom surgery did not resulted in significant bleeding
Overall Number of Participants Analyzed 541 35 863
Measure Type: Number
Unit of Measure: number of participants
transfusion of pack red blood cell 33 31 1
no transfusion 508 4 862
3.Secondary Outcome
Title Preoperative Anemia
Hide Description proportion of patients with preoperative anemia
Time Frame one day
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Lowest Hemoglobin
Hide Description lowest peroperative hemoglobin concentration
Time Frame one day
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Unanticipated Bleeding No Peroperative Significant Bleeding
Hide Arm/Group Description

Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.

Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL.

Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.

Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.

Patients for whom surgery did not result in significant bleeding
All-Cause Mortality
Control Unanticipated Bleeding No Peroperative Significant Bleeding
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Unanticipated Bleeding No Peroperative Significant Bleeding
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Control Unanticipated Bleeding No Peroperative Significant Bleeding
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
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: Dr Jean-Luc Hanouz
Organization: CHU de Caen
Phone: 2 31 06 47 36 ext 33
EMail: hanouz-jl@chu-caen.fr
Layout table for additonal information
Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02311309     History of Changes
Other Study ID Numbers: A13-D48-VOL.19
First Submitted: December 4, 2014
First Posted: December 8, 2014
Results First Submitted: February 9, 2016
Results First Posted: April 21, 2016
Last Update Posted: April 21, 2016