Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005308
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Anemia and Surgery Indications For Transfusion
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To estimate the risk of death for patients with different pre- and post-operative hemoglobin levels who do not receive blood transfusions and to derive a multivariate model using clinical information available pre-operatively that would predict the risk of death post-operatively
Detailed Description:
BACKGROUND
The AIDS epidemic has focused considerable attention on the risks associated with blood transfusions Perhaps of more importance hemolytic transfusion reactions and post-transfusion non-A non-B hepatitis continue to be significant concerns However guidelines for blood transfusions in the surgical patient vary considerably in the medical literature Some recent texts stress the need to consider factors such as patients age surgical procedure co-morbid illness predicted blood loss and cause of the anemia as well as the hemoglobin level Nonetheless in practice many surgeons still adhere to the 10gdl threshold for transfusion The lack of consensus guidelines can probably be attributed to the dearth of studies exploring the indications for transfusion The few studies which have examined this question are limited because they fail to analyze subsets of patients by age co-morbid illness or blood loss The need to develop peri-operative transfusion guidelines based on multivariate analysis therefore decreasing the frequency of unnecessary transfusions resulting from the common use of a hemoglobin threshold is especially important in light of the hazards and costs associated with blood transfusions Jehovahs Witnesses were chosen as the study population because they decline blood transfusion for religious reasons
DESIGN NARRATIVE
The retrospective case-control study explored the possible associations between peri-operative anemia and post-operative mortality status Cases were defined as those who died within 30 days of the operative procedure and controls as all those who survived There were approximately eight controls per case Participating surgeons who operated on Jehovahs Witness patients within the preceeding five years provide a list of patients Charts of patients were reviewed to determine if any died within 30 days of surgery If the patient was discharged prior to 30 days postoperatively then the National Death Index was used to assess the patients status 30 days after surgery The incidence of post-operative death with 95 percent confidence levels was calculated for strata of pre- and post-operative hemoglobin levels and operative blood loss The death rate was calculated after stratifying the patients based on status with regard to co-morbid diseases or other possible risk factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The AIDS epidemic has focused considerable attention on the risks associated with blood transfusions Perhaps of more importance hemolytic transfusion reactions and post-transfusion non-A non-B hepatitis continue to be significant concerns However guidelines for blood transfusions in the surgical patient vary considerably in the medical literature Some recent texts stress the need to consider factors such as patients age surgical procedure co-morbid illness predicted blood loss and cause of the anemia as well as the hemoglobin level Nonetheless in practice many surgeons still adhere to the 10gdl threshold for transfusion The lack of consensus guidelines can probably be attributed to the dearth of studies exploring the indications for transfusion The few studies which have examined this question are limited because they fail to analyze subsets of patients by age co-morbid illness or blood loss The need to develop peri-operative transfusion guidelines based on multivariate analysis therefore decreasing the frequency of unnecessary transfusions resulting from the common use of a hemoglobin threshold is especially important in light of the hazards and costs associated with blood transfusions Jehovahs Witnesses were chosen as the study population because they decline blood transfusion for religious reasons
DESIGN NARRATIVE
The retrospective case-control study explored the possible associations between peri-operative anemia and post-operative mortality status Cases were defined as those who died within 30 days of the operative procedure and controls as all those who survived There were approximately eight controls per case Participating surgeons who operated on Jehovahs Witness patients within the preceeding five years provide a list of patients Charts of patients were reviewed to determine if any died within 30 days of surgery If the patient was discharged prior to 30 days postoperatively then the National Death Index was used to assess the patients status 30 days after surgery The incidence of post-operative death with 95 percent confidence levels was calculated for strata of pre- and post-operative hemoglobin levels and operative blood loss The death rate was calculated after stratifying the patients based on status with regard to co-morbid diseases or other possible risk factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL041523 | NIH | None | httpsreporternihgovquickSearchR01HL041523 |