Fort 1990.
Methods | Randomised: yes, by a table of random numbers. Concealment: method not described. Double‐blind: no. Description of withdrawals/dropouts: no Length of FU: until discharge. Jadad score: 2/5. | |
Participants | Country: France. Diagnosis of bleeding: by endoscopy. Source of bleeding: 100% confirmed or unconfirmed varices. Endoscopy performed in all patients prior to randomisation. Diagnosis of cirrhosis: Clinical or histological (PC). 34 patients with 47 episodes. Child's A = 15%, B = 30%, C = 55%. Alcoholic cirrhosis = 68%. | |
Interventions | Terlipressin versus balloon tamponade. R x 1: terlipressin 2 mg iv once, then 1mg iv every six hours for 30 h plus NTG 0.4mg. SL every 20 min for the first 6 h. R x 2: Sengstaken‐Blakemore tube for 24 h. Time from admission to treatment: unknown. Initial sclerotherapy: none. |
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Outcomes | 1. Mortality at discharge. 2. Failure of initial haemostasis at 12 h. 3. Rebleeding 12‐48 h. 4. Procedures required for haemostasis: PC 5. Blood transfusions. 6. LOS: NR. | |
Notes | Source of funding: Included in hospital costs (PC). Patients in either group who continued to bleed at the end of 12 h received the alternative treatment (i.e., patients in the terlipressin group received balloon tamponade and vice versa). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |