Terry Varizen

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Terry Varizen

N Engl J Med ; Comments open through January 8, The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial.

We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy. Full Text of Background We enrolled patients with severe acute upper gastrointestinal bleeding and randomly assigned of them to a restrictive strategy transfusion when the hemoglobin level fell below 7 g per deciliter and to a liberal strategy transfusion when the hemoglobin fell below 9 g per deciliter.

Randomization was stratified according terry Varizen the presence or absence of liver cirrhosis. Full Text of Methods The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the terry Varizen of patients who had bleeding associated with a peptic ulcer hazard ratio, 0.

Full Text of Results As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding. Full Text of Discussion Acute upper terry Varizen bleeding is a common emergency condition associated with high morbidity and mortality.

Transfusion may be lifesaving in patients with massive exsanguinating bleeding. However, in most cases hemorrhage is not so severe, and in such circumstances the safest and most effective transfusion strategy is controversial, terry Varizen.

Restricted transfusion strategies may be appropriate in some settings. Controlled trials have shown that for critically ill patients, a restrictive transfusion strategy is at least as effective as a liberal strategy, while substantially reducing the use of blood supplies. Observational studies and small controlled trials have suggested that transfusion may be harmful in patients with hypovolemic anemia, 6,7 even in those with gastrointestinal bleeding.

We performed a randomized, controlled trial in which we assessed whether a restrictive threshold for red-cell transfusion in patients with acute gastrointestinal bleeding was safer and more effective than a liberal transfusion strategy that was based on the threshold recommended in guidelines at the time the study was designed.

From June through Decemberwe consecutively enrolled patients with gastrointestinal bleeding who were admitted to Hospital de la Santa Creu i Sant Pau in Barcelona. Written informed consent was obtained from all the patients or their next of kin, terry Varizen, and the trial was approved by the institutional ethics committee at the hospital.

The protocolincluding the statistical analysis terry Varizen, is available with the full text of this article at NEJM.

No commercial terry Varizen was involved in the study, terry Varizen. All the authors vouch for the integrity and the accuracy of the analysis and for the fidelity of the study to the protocol. No one who terry Varizen not an author contributed to the manuscript.

Patients older than 18 years of age who had terry Varizen or bloody nasogastric aspiratemelena, or both, terry Varizen, as confirmed by the hospital staff, were considered for inclusion. Patients were excluded if they declined to undergo a blood transfusion. Additional exclusion criteria were massive exsanguinating bleeding; an acute coronary syndrome, symptomatic peripheral vasculopathy, stroke, transient ischemic attack, or transfusion within the previous 90 days; a recent history of trauma or surgery; lower gastrointestinal bleeding; a previous decision on the part of the attending physician that the terry Varizen should avoid specific medical therapy; and a clinical Rockall score of 0 with a hemoglobin level higher than 12 g per deciliter.

The Rockall score is a system for assessing the risk of further bleeding or death among patients with gastrointestinal bleeding; scores range from 0 to 11, with a score of 2 or lower indicating low risk and scores of 3 to 11 indicating increasingly greater risk.

Immediately after admission, terry Varizen, patients were randomly assigned to a restrictive transfusion strategy or a liberal transfusion strategy. Randomization was performed with the use of computer-generated random numbers, terry Varizen, with the group assignments placed in sealed, terry Varizen, consecutively numbered, opaque envelopes. Randomization was stratified according to the presence or absence of liver cirrhosis and was performed in blocks of four.

Cirrhosis was diagnosed according to clinical, biochemical, and ultrasonographic findings. In the restrictive-strategy group, terry Varizen, the hemoglobin threshold for transfusion was 7 g per deciliter, with a target range for the post-transfusion hemoglobin level of 7 to 9 g per deciliter.

In the liberal-strategy group, terry Varizen, the hemoglobin threshold for transfusion was 9 g per deciliter, with a target range for the post-transfusion hemoglobin level of 9 to 11 g per deciliter. In both groups, 1 unit of red cells was transfused initially; the hemoglobin level was assessed after terry Varizen transfusion, and an additional unit was transfused if the hemoglobin level was below the threshold value.

The transfusion protocol was applied until the patient's discharge from the hospital or death. The protocol allowed for a transfusion to be administered any time symptoms or signs related to anemia developed, terry Varizen, massive bleeding occurred during follow-up, or surgical intervention was required.

Only prestorage leukocyte-reduced units of packed red cells were used for transfusion. Hemoglobin levels were measured after admission and again every 8 hours during the first terry Varizen days and every day thereafter. Hemoglobin levels were also assessed when further bleeding was suspected, terry Varizen.

All the patients underwent emergency gastroscopy within the first 6 hours. When endoscopic examination disclosed a nonvariceal lesion with active arterial bleeding, a nonbleeding visible vessel, terry Varizen, or an adherent clot, terry Varizen, patients underwent endoscopic therapy with injection of adrenaline plus multipolar electrocoagulation or application of endoscopic clips.

Patients with peptic ulcer received a continuous intravenous infusion of omeprazole 80 mg per hour period after an initial bolus of 80 mg for the first 72 hours, terry Varizen, followed by oral administration of omeprazole.

Bleeding esophageal varices were also treated with band ligation or with sclerotherapy, and gastric varices with injection of cyanoacrylate. In patients with variceal bleeding, portal pressure was measured within the first 48 hours and again 2 to 3 days later to assess the effect of the transfusion strategy on portal hypertension. Portal pressure was estimated with the use of the hepatic venous pressure gradient HVPGas described elsewhere, terry Varizen. The primary outcome measure was the die Zeit der Rehabilitation nach der Operation von Krampfadern of death from any cause within the first 45 days.

Secondary terry Varizen included the rate of further bleeding and the rate of in-hospital complications, terry Varizen. Further bleeding was considered to indicate therapeutic failure; terry Varizen the bleeding involved nonvariceal lesions, the patient underwent repeat endoscopic therapy or emergency surgery, whereas in the case of further variceal bleeding, transjugular intrahepatic portosystemic shunting TIPS was considered.

Complications were defined as any untoward events that necessitated active therapy or prolonged hospitalization. Side effects were considered to be severe if the health or safety of the patient was endangered. The statistical analysis was performed according to the intention-to-treat principle. Standard tests were used for comparisons of proportions and means. Continuous variables are expressed as means and standard deviations. Actuarial probabilities were calculated with the use of the Kaplan—Meier method and were compared with the use of the log-rank test.

A Cox proportional-hazards regression model was used to compare the two transfusion-strategy groups with respect to the primary and secondary end points, with adjustment for baseline risk factors see the Supplementary Appendixavailable at NEJM. Data were censored at the time an end-point event occurred, at the patient's last visit, or at the end of the day follow-up period, whichever occurred first.

Prespecified subgroup analyses were performed to assess the efficacy of transfusion strategies according to the source of bleeding lesions related to portal hypertension or peptic ulcer. All P values are two-tailed. Calculations were performed with the use of the SPSS statistical package, terry Varizen, version During the study period, patients were admitted to the hospital for gastrointestinal bleeding and were screened. Of these, 41 declined to participate and were excluded; among the reasons for exclusion were exsanguinating bleeding requiring transfusion in 39 patients and a low risk of rebleeding patients Figure 1 Figure 1 Screening, terry Varizen, Randomization, and Follow-up.

During the study period, terry Varizen, patients with gastrointestinal bleeding were screened, and patients were excluded.

The reasons for exclusion included massive exsanguinating bleeding requiring transfusion before randomization 39 patients and a low risk terry Varizen rebleeding patients. A low risk of rebleeding was defined as a clinical Rockall score of 0 and hemoglobin levels higher than 12 g per deciliter. The Rockall score is a system for assessing the risk of further bleeding or death among patients with gastrointestinal bleeding; scores range from 0 to 11, with higher scores indicating greater risk.

Patients were also excluded if they declined blood transfusion 14 patients ; other exclusion criteria were an acute coronary syndrome 58symptomatic peripheral vasculopathy 12stroke or transient ischemic attack 7or transfusion 10 within the previous 90 days; lower gastrointestinal bleeding terry Varizen ; pregnancy 3 ; a recent history of trauma or surgery 41 ; a decision by the attending physician that the patient should avoid medical therapy 9 ; or inclusion in this study within the previous 90 days or inclusion more than twice A total of patients underwent randomization, of whom 32 were withdrawn: A total of patients underwent randomization and 32 withdrew or were withdrawn by the investigators after terry Varizen see Figure 1 for detailsterry Varizen, leaving patients in the restrictive-strategy group and in the liberal-strategy group for the intention-to-treat analysis.

The baseline characteristics were similar terry Varizen the two groups Table 1 Table 1 Baseline Characteristics of the Patients. The hemoglobin concentration at admission was similar in the two groups Table 2 Table 2 Hemoglobin Levels, Transfusions, and Cointerventions.

The percentage of patients in whom the lowest hemoglobin level was less than 7 g per deciliter was higher in the restrictive-strategy group than in the liberal-strategy group. Terry Varizen hemoglobin concentration at 45 days was similar in the two groups. The percentage of patients who received a transfusion of fresh-frozen plasma, terry Varizen, the percentage of patients who received a transfusion of platelets, terry Varizen, and the total amount of fluid administered were similar in the terry Varizen groups, terry Varizen.

Mortality at 45 days was significantly lower in the restrictive-strategy group than in the liberal-strategy group: Panel A shows the Kaplan—Meier estimates of the 6-week survival rate in the two groups. The probability of survival was significantly higher in the restrictive-strategy group than in the liberal-strategy group.

The gray arrows indicate the day on which data from a patient were censored. The inset shows the same data on an enlarged y axis. The risk of death was virtually unchanged after adjustment for baseline risk factors for death hazard ratio with restrictive strategy, 0. Among all patients with cirrhosis, the risk of death was slightly lower in the restrictive-strategy group than in the liberal-strategy group Figure 2.

In the subgroup of patients with cirrhosis and Child—Pugh class A or B disease, the risk of death was significantly lower among patients in the restrictive-strategy group than among those in the liberal-strategy group, whereas in the subgroup of patients with cirrhosis and Child—Pugh class C disease, the risk was similar in the terry Varizen groups, terry Varizen.

Among patients with bleeding from a peptic ulcer, the risk of death was slightly lower with the restrictive strategy than with the liberal strategy. Death was due to unsuccessfully controlled bleeding in 3 patients 0. Death was caused by complications of treatment in 3 patients 2 in the liberal-strategy group and 1 in the restrictive-strategy group.

In the remaining 44 patients 19 in the restrictive-strategy group and 25 in the liberal-strategy groupterry Varizen, hemorrhage was controlled and death was due to associated diseases. The rate of further bleeding was significantly lower in the restrictive-strategy group than in the terry Varizen group: The terry Varizen of further bleeding was significantly lower with the restrictive strategy after adjustment for baseline risk factors for further bleeding hazard ratio, 0.

In addition, the length of hospital stay was shorter in the restrictive-strategy group than in the liberal-strategy group. In the subgroup of patients with cirrhosis, the risk of further bleeding was lower with the restrictive transfusion strategy than with the liberal transfusion strategy among patients terry Varizen Child—Pugh class A or B disease and was similar in the two groups among patients with Child—Pugh class C disease Table 3.

Rescue therapy with balloon tamponade or with transjugular intrahepatic portosystemic shunt was required less frequently in the restrictive-strategy group than in the liberal-strategy group.

A baseline hepatic hemodynamic study was performed in 86 patients in the restrictive-strategy group and in 89 in the liberal-strategy group, and it was repeated 2 to 3 days later in 74 and 77 patients, terry Varizen, respectively, to assess changes. Patients in the liberal-strategy group had a significant increase in the mean hepatic venous pressure gradient between the first hemodynamic study and the second from There was no significant change in mean hepatic venous pressure gradient in the restrictive-strategy group during that interval.

Among patients with bleeding from a peptic ulcer, there was a trend toward a lower risk of further bleeding in the restrictive-strategy group Table 3. Transfusion reactions and cardiac events, mainly pulmonary edema, occurred more frequently in the liberal-strategy group Table 3, terry Varizen. The rates of other adverse events, such as acute kidney injury or bacterial infections, did not differ significantly between the groups Table S5 in the Supplementary Appendix.

We found that among patients with severe acute upper gastrointestinal bleeding, the outcomes were significantly improved with a restrictive transfusion strategy, in which the hemoglobin threshold terry Varizen 7 g per deciliter, as compared with a liberal transfusion strategy, in which the hemoglobin threshold was 9 g per deciliter.


Terry Varizen

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