-
1.
Medical interventions for traumatic hyphema
Woreta, F. A., Lindsley, K. B., Gharaibeh, A., Ng, S. M., Scherer, R. W., Goldberg, M. F.
The Cochrane Database of Systematic Reviews. 2023;3(3):Cd005431
Abstract
BACKGROUND Traumatic hyphema is the entry of blood into the anterior chamber, the space between the cornea and iris, following significant injury to the eye. Hyphema may be associated with significant complications that uncommonly cause permanent vision loss. Complications include elevated intraocular pressure, corneal blood staining, anterior and posterior synechiae, and optic nerve atrophy. People with sickle cell trait or disease may be particularly susceptible to increases in intraocular pressure and optic atrophy. Rebleeding is associated with an increase in the rate and severity of complications. OBJECTIVES To assess the effectiveness of various medical interventions in the management of traumatic hyphema. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2022, Issue 3); MEDLINE Ovid; Embase.com; PubMed (1948 to March 2022); the ISRCTN registry; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). The last date of the search was 22 March 2022. SELECTION CRITERIA Two review authors independently assessed the titles and abstracts of all reports identified by the electronic and manual searches. We included randomized and quasi-randomized trials that compared various medical (non-surgical) interventions versus other medical interventions or control groups for the treatment of traumatic hyphema following closed-globe trauma. We applied no restrictions on age, gender, severity of the closed-globe trauma, or level of visual acuity at time of enrollment. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane and assessed the certainty of evidence using GRADE. MAIN RESULTS We included 23 randomized and seven quasi-randomized studies with a total of 2969 participants. Interventions included antifibrinolytic agents (systemic and topical aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), corticosteroids (systemic and topical), cycloplegics, miotics, aspirin, conjugated estrogens, traditional Chinese medicine, monocular versus bilateral patching, elevation of the head, and bed rest. We found no evidence of an effect on visual acuity for any intervention, whether measured within two weeks (short term) or for longer periods. In a meta-analysis of two trials, we found no evidence of an effect of aminocaproic acid on long-term visual acuity (RR 1.03, 95% confidence interval (CI) 0.82 to 1.29) or final visual acuity measured up to three years after the hyphema (RR 1.05, 95% CI 0.93 to 1.18). Oral tranexamic acid appeared to provide little to no benefit on visual acuity in four trials (RR 1.12, 95% CI 1.00 to 1.25). The remaining trials evaluated the effects of various interventions on short-term visual acuity; none of these interventions was measured in more than one trial. No intervention showed a statistically significant effect (RRs ranged from 0.75 to 1.10). Similarly, visual acuity measured for longer periods in four trials evaluating different interventions was also not statistically significant (RRs ranged from 0.82 to 1.02). The evidence supporting these findings was of low or very low certainty. Systemic aminocaproic acid reduced the rate of recurrent hemorrhage (RR 0.28, 95% CI 0.13 to 0.60), as assessed in six trials with 330 participants. A sensitivity analysis omitting two studies not using an intention-to-treat analysis reduced the strength of the evidence (RR 0.43, 95% CI 0.17 to 1.08). We obtained similar results for topical aminocaproic acid (RR 0.48, 95% CI 0.20 to 1.10) in two trials with 131 participants. We assessed the certainty of the evidence as low. Systemic tranexamic acid had a significant effect in reducing the rate of secondary hemorrhage (RR 0.33, 95% CI 0.21 to 0.53) in seven trials with 754 participants, as did aminomethylbenzoic acid (RR 0.10, 95% CI 0.02 to 0.41), as reported in one study. Evidence to support an associated reduction in risk of complications from secondary hemorrhage (i.e. corneal blood staining, peripheral anterior synechiae, elevated intraocular pressure, and development of optic atrophy) by antifibrinolytics was limited by the small number of these events. Use of aminocaproic acid was associated with increased nausea, vomiting, and other adverse events compared with placebo. We found no evidence of an effect on the number of adverse events with the use of systemic versus topical aminocaproic acid or with standard versus lower drug dose. The number of days for the primary hyphema to resolve appeared to be longer with the use of systemic aminocaproic acid compared with no use, but this outcome was not altered by any other intervention. The available evidence on usage of systemic or topical corticosteroids, cycloplegics, or aspirin in traumatic hyphema was limited due to the small numbers of participants and events in the trials. We found no evidence of an effect between a single versus binocular patch on the risk of secondary hemorrhage or time to rebleed. We also found no evidence of an effect on the risk of secondary hemorrhage between ambulation and complete bed rest. AUTHORS' CONCLUSIONS We found no evidence of an effect on visual acuity of any of the interventions evaluated in this review. Although the evidence was limited, people with traumatic hyphema who receive aminocaproic acid or tranexamic acid are less likely to experience secondary hemorrhage. However, hyphema took longer to clear in people treated with systemic aminocaproic acid. There is no good evidence to support the use of antifibrinolytic agents in the management of traumatic hyphema, other than possibly to reduce the rate of secondary hemorrhage. The potentially long-term deleterious effects of secondary hemorrhage are unknown. Similarly, there is no evidence to support the use of corticosteroids, cycloplegics, or non-drug interventions (such as patching, bed rest, or head elevation) in the management of traumatic hyphema. As these multiple interventions are rarely used in isolation, further research to assess the additive effect of these interventions might be of value.
-
2.
Is Antifibrinolytic Therapy Effective for Preventing Hemorrhage in Patients with Hemophilia Undergoing Dental Extractions? A Systematic Review and Meta-Analysis
Ullah, K., Mukhtar, H., Khalid, U., Sarfraz, Z., Sarfraz, A.
Clinical and Applied Thrombosis/Hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2022;28:10760296221114862
Abstract
OBJECTIVES This systematic review aims to analyze the systemic administration of antifibrinolytics (tranexamic acid and aminocaproic acid) to prevent postoperative bleeding in patients with hemophilia. METHODS This systematic review was conducted adhering to PRISMA guidelines. Only randomized controlled trials that assessed human subjects of any age or gender with any severity of hemophilia undergoing dental extractions, and systemically administered antifibrinolytic therapy compared to placebo were included. Post-operative bleeding episodes and adverse events were presented. PubMed, Cochrane, Embase, CINAHL, Web of Science, and Scopus were searched through April 15, 2022. The risk ratio (RR) and odds ratio (OR) applying 95% confidence intervals (CI) were computed using RevMan 5.4.1 (Cochrane). RESULTS Two randomized, placebo-controlled trials pooling in a total of 59 patients were pooled in this analysis. Among patients administered antifibrinolytic therapy, 84% reduced risk of post-operative bleeding was reported (RR = 0.16, 95% CI = 0.05-0.47, P = 0.0009). The chances of post-operative bleeding were reduced by 95% among the antifibrotics group (OR = 0.05, 95% CI = 0.01-0.22, P < 0.0001). CONCLUSION This review finds favorable outcomes for the routine use of antifibrinolytic therapy for dental extractions in hemophiliacs. Further trials are required to rationalize existing evidence.
-
3.
Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo controlled, randomized clinical trial
Gernsheimer TB, Brown SP, Triulzi DJ, Key NS, El Kassar N, Herren H, Poston JN, Boyiadzis M, Reeves BN, Selukar S, et al
Blood. 2022
-
-
-
Free full text
-
Full text
-
Editor's Choice
Abstract
Evidence of effectiveness of prophylactic use of tranexamic acid (TXA) in thrombocytopenia is lacking. To determine whether TXA safely reduces bleeding incidence in patients undergoing treatment for hematologic malignancies, a randomized double blind clinical trial was conducted June 2016 through June 2020. Of 3120 screened adults 356 patients were eligible and enrolled, and 337 patients (mean age, 53.9; 141 (41.8%) women), randomized to 1,300mg TXA orally or 1,000mg TXA intravenously (n=168) versus placebo (n=169) thrice daily for maximum 30 days. 330 patients were activated when their platelet counts fell below 30,000/µl; 279 (83%) had complete outcome ascertainment. WHO grade 2 or higher bleeding was observed in the 30 days following activation in 50.3% (73/145) and 54.2% (78/144) of patients in the TXA and placebo groups, adjusted odds ratio: 0.83 (95%CI:0.50,1.34; p=0.44). There was no statistically significant difference in mean number of platelet transfusions (0.1;95%CI:-1.9,2.0), mean days alive without grade 2 or higher bleeding (0.8;95%CI:-0.4,2.0), thrombotic events (6/163 (3.7%) TXA, 9/163 (5.5%) placebo), or deaths due to serious bleeding. Most common adverse events were: diarrhea [(116/164 (70.7%) TXA and 114/163 (69.9%) placebo)]; febrile neutropenia [111/164 (67.7%) TXA, 105/163 (64.4%) placebo]; fatigue [106/164 (64.6%) TXA, 109/163 (66.9%) placebo]; and nausea [104/164 (63.4%) TXA, 97/163 (59.5%) placebo]. Among patients with hematologic malignancy undergoing chemotherapy or hematopoietic stem cell transplantation, prophylactic treatment with tranexamic acid compared with placebo did not significantly reduce the risk of WHO grade 2 or higher bleeding. Trial Registration: Clinicaltrials.gov Identifier: NCT02578901.
PICO Summary
Population
Patients who were thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy, and/or radiation therapy (n= 337).
Intervention
Tranexamic acid (TXA) orally or intravenously (n= 168).
Comparison
Placebo (n= 169).
Outcome
The primary outcome of WHO grade 2 or higher bleeding during the first 30 days after activation was observed for 73 out of 145 (50.3%) and 78 out of 144 (54.2%) patients in the TXA and placebo groups, respectively. There was no statistically significant difference in mean number of platelet transfusions (0.1), mean days alive without grade 2 or higher bleeding (0.8), thrombotic events (6/163 (3.7%) TXA, 9/163 (5.5%) placebo), or deaths due to serious bleeding.
-
4.
Palliative interventions for controlling vaginal bleeding in advanced cervical cancer
Eleje GU, Eke AC, Igberase GO, Igwegbe AO, Eleje LI
The Cochrane database of systematic reviews. 2019;3:Cd011000
Abstract
BACKGROUND This is an updated version of the original Cochrane review published in Issue 5, 2015.Cervical cancer is the fourth most common cancer among women worldwide, with estimated 569,847 new diagnoses and 311,365 deaths per year. However, incidence and stage at diagnosis vary greatly between geographic areas and are largely dependent on the availability of a robust population screening programme. For example, in Nigeria, advanced-stage disease at presentation is common (86% to 89.3% of new cases), whereas in the UK, only 21.9% of women present with International Federation of Gynaecology and Obstetrics (FIGO) stage II+ disease. Women with advanced cancer of the cervix often need palliation for distressing symptoms, such as vaginal bleeding. Vaginal bleeding can be life threatening in advanced disease, with an incidence ranging from 0.7% to 100%. Bleeding is the immediate cause of death in 6% of women with cervical cancer and its management often poses a challenge.Thus, vaginal bleeding remains a common consequence of advanced cervical cancer. Currently, there is no systematic review that addresses palliative interventions for controlling vaginal bleeding caused by advanced cervical cancer. A systematic evaluation of the available palliative interventions is needed to inform decision-making. OBJECTIVES To evaluate the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy for palliative treatment of vaginal bleeding in women with advanced cervical cancer. SEARCH METHODS The search for the original review was run in 23 March 2015, and subsequent searches for this update were run 21 March 2018. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid to March week 2, 2018; and Embase via Ovid to March week 12, 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles, and contacted experts in the field. We handsearched citation lists of relevant studies. SELECTION CRITERIA We searched for randomised and non-randomised comparative studies that evaluated the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy techniques for palliative treatment of vaginal bleeding in women with advanced cervical cancer (with or without metastasis), irrespective of publication status, year of publication or language in the review. DATA COLLECTION AND ANALYSIS Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies for inclusion and, therefore, we analysed no data. MAIN RESULTS The search strategy identified 1522 unique references of which we excluded 1330 on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer. AUTHORS' CONCLUSIONS Since the last version of this review we found no new studies. There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.
-
5.
Does tranexamic acid reduce blood loss during head and neck cancer surgery?
Kulkarni AP, Chaukar DA, Patil VP, Metgudmath RB, Hawaldar RW, Divatia JV
Indian Journal of Anaesthesia. 2016;60((1)):19-24.
Abstract
BACKGROUND AND AIMS Transfusion of blood and blood products poses several hazards. Antifibrinolytic agents are used to reduce perioperative blood loss. We decided to assess the effect of tranexamic acid (TA) on blood loss and the need for transfusion in head and neck cancer surgery. METHODS After Institutional Review Board approval, 240 patients undergoing supramajor head and neck cancer surgeries were prospectively randomised to either TA (10 mg/kg) group or placebo (P) group. After induction, the drug was infused by the anaesthesiologist, who was blinded to allocation, over 20 min. The dose was repeated every 3 h. Perioperative (up to 24 h) blood loss, need for transfusion and fluid therapy was recorded. Thromboelastography (TEG) was performed at fixed intervals in the first 100 patients. Patients were watched for post-operative complications. RESULTS Two hundred and nineteen records were evaluable. We found no difference in intraoperative blood loss (TA - 750 [600-1000] ml vs. P - 780 [150-2600] ml, P = 0.22). Post-operative blood loss was significantly more in the placebo group at 24 h (P - 200 [120-250] ml vs. TA - 250 [50-1050] ml, P = 0.009), but this did not result in higher number of patients needing transfusions (TA - 22/108 and P - 27/111 patients, P = 0.51). TEG revealed faster clot formation and minimal fibrinolysis. Two patients died of causes unrelated to study drug. Incidence of wound complications and deep venous thrombosis was similar. CONCLUSION In head and neck cancer surgery, TA did not reduce intraoperative blood loss or need for transfusions. Perioperative TEG variables were similar. This may be attributed to pre-existing hypercoagulable state and minimal fibrinolysis in cancer patients.
-
6.
Antifibrinolytics (lysine analogues) for the prevention of bleeding in people with haematological disorders
Estcourt LJ, Desborough M, Brunskill SJ, Doree C, Hopewell S, Murphy MF, Stanworth SJ
The Cochrane Database of Systematic Reviews. 2016;((3)):CD009733.
Abstract
BACKGROUND People with haematological disorders are frequently at risk of severe or life-threatening bleeding as a result of thrombocytopenia (reduced platelet count). This is despite the routine use of prophylactic platelet transfusions to prevent bleeding once the platelet count falls below a certain threshold. Platelet transfusions are not without risk and adverse events may be life-threatening. A possible adjunct to prophylactic platelet transfusions is the use of antifibrinolytics, specifically the lysine analogues tranexamic acid (TXA) and epsilon aminocaproic acid (EACA). This is an update of a Cochrane review first published in 2013. OBJECTIVES To determine the efficacy and safety of antifibrinolytics (lysine analogues) in preventing bleeding in people with haematological disorders. SEARCH METHODS We searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (The Cochrane Library 2016, Issue 3), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950) and ongoing trial databases to 07 March 2016. SELECTION CRITERIA We included RCTs involving participants with haematological disorders, who would routinely require prophylactic platelet transfusions to prevent bleeding. We only included trials involving the use of the lysine analogues TXA and EACA. DATA COLLECTION AND ANALYSIS Two review authors independently screened all electronically-derived citations and abstracts of papers, identified by the review search strategy, for relevancy. Two review authors independently assessed the full text of all potentially relevant trials for eligibility, completed the data extraction and assessed the studies for risk of bias using The Cochrane Collaboration's 'Risk of bias' tool. We requested missing data from one author but the data were no longer available. The outcomes are reported narratively: we performed no meta-analyses because of the heterogeneity of the available data. MAIN RESULTS We identified three new studies in this update of the review. In total seven studies were eligible for inclusion, three were ongoing RCTs and four were completed studies. The four completed studies were included in the original review and the three ongoing studies were included in this update. We did not identify any RCTs that compared TXA with EACA.Of the four completed studies, one cross-over TXA study (eight participants) was excluded from the outcome analysis because it had very flawed study methodology. Data from the other three studies were all at unclear risk of bias due to lack of reporting of study methodology.Three studies (two TXA (12 to 56 participants), one EACA (18 participants) reported in four articles (published 1983 to 1995) were included in the narrative review. All three studies compared the drug with placebo. All three studies included adults with acute leukaemia receiving chemotherapy. One study (12 participants) only included participants with acute promyelocytic leukaemia. None of the studies included children. One of the three studies reported funding sources and this study was funded by a charity.We are uncertain whether antifibrinolytics reduce the risk of bleeding (three studies; 86 participants; very low-quality evidence). Only one study reported the number of bleeding events per participant and there was no difference in the number of bleeding events seen during induction or consolidation chemotherapy between TXA and placebo (induction; 38 participants; mean difference (MD) 1.70 bleeding events, 95% confidence interval (CI) -0.37 to 3.77: consolidation; 18 participants; MD -1.50 bleeding events, 95% CI -3.25 to 0.25; very low-quality evidence). The two other studies suggested bleeding was reduced in the antifibrinolytic study arm, but this was statistically significant in only one of these two studies.Two studies reported thromboembolism and no events occurred (68 participants, very low-quality evidence).All three studies reported a reduction in platelet transfusion usage (three studies, 86 participants;
-
7.
Does the preoperative administration of tranexamic acid reduce perioperative blood loss and transfusion requirements after head neck cancer surgery? A randomized, controlled trial
Das A, Chattopadhyay S, Mandal D, Chhaule S, Mitra T, Mukherjee A, Mandal SK, Chattopadhyay S
Albang Maqalat Wa Abhat Fi Altahdir Waalinas. 2015;9((3)):384-90.
Abstract
BACKGROUND Head and neck cancer (HNC) surgery is associated with high intraoperative blood loss which may require urgent blood transfusion. Many strategies have been recommended to decrease the need for allogenic transfusion. Use of perioperative tranexamic acid (TA) has a promising role. AIMS This study was to evaluate the effectiveness of single preoperative bolus dose of TA on blood loss prevention and red blood cell transfusion in patients undergoing HNC surgery. STUDY DESIGN A prospective, double-blind, and randomized controlled study. MATERIALS AND METHODS From 2007 July to 2010 January; 80 patients, aged (35-55), of American Society of Anesthesiologists II-III scheduled for unilateral HNC surgeries were randomly received either TA (Group T) in a dose of 20 mg/kg diluted to 25 cc with normal saline or an equivalent volume of normal saline (Group C) in a tertiary care hospital. Hemoglobin (Hb) concentration, platelet count, packed cell volume, fibrinogen level, D-dimer level were measured pre- and post-operatively. RESULTS Saline (C) Group required more blood, colloid, crystalloid for blood loss. In Group T, 32 patients did not require transfusion of any blood products compared to five patients in Group C (P < 0.0001) and only eight units of blood was transfused in Group T, whereas a total of 42 units of blood was transfused in Group C. Even after numerous transfusions, Hb% after 6 h and 24 h in Group C were significantly low in comparison with Group T (P < 0.05). CONCLUSION Thus, TA significantly reduces blood loss and chances of colloid, blood, and crystalloid transfusion caused by HNC surgery.
-
8.
Efficacy of tranexamic acid mouthwash as an alternative for factor replacement in gingival bleeding during dental scaling in cases of hemophilia: A randomized clinical trial
Nuvvula S, Gaddam KR, Kamatham R
Contemporary Clinical Dentistry. 2014;5((1):):49-53.
Abstract
OBJECTIVE The objective of the following study is to evaluate freshly prepared tranexamic acid mouth wash (FTAMW) as an alternative to factor replacement therapy (FRT) in controlling gingival bleeding in hemophiliacs during dental scaling. MATERIALS AND METHODS Experimental treatment regime (ETR) involved saline transfusion followed by FTAMW and the control treatment regime (CTR) involved FRT followed by placebo mouthwash. A total of 22 hemophiliacs randomly received dental scaling under either CTR or ETR at two different visits, following a split mouth design. They were instructed to use the rendered mouthwash 4 times a day for 5 days and record the mouthwash usage and bleeding episodes in a logbook. The difference in the bleeding episodes was analyzed using Chi-square test with the level of significance predetermined at 0.05. RESULTS Totally 19 patients completed the study. Seven patients reported no bleeding either in ETR or CTR; five patients noticed bleeding in CTR, but not in ETR. Three patients noticed bleeding in ETR, but not in CTR. Patients reported ease in usage and cost-effectiveness of ETR. CONCLUSION FTAMW was found to be an effective alternative to FRT in controlling gingival hemorrhage in hemophiliacs during dental scaling.
-
9.
Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study
Lundin ES, Johansson T, Zachrisson H, Leandersson U, Backman F, Falknas L, Kjolhede P
Acta Obstetricia et Gynecologica Scandinavica. 2014;93((4):):335-44.
Abstract
OBJECTIVE To determine whether single-dose tranexamic acid given intravenously immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and blood transfusions. DESIGN A randomized double-blind, placebo-controlled multicenter study. SETTING Two university hospitals and two central hospitals in the southeast health region of Sweden. POPULATION One hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery between March 2008 and May 2012 who complied with inclusion/exclusion criteria were randomized; 50 were allocated to receive tranexamic acid and 50 to receive placebo. Analysis was performed according to intention-to-treat principles. METHODS The volume of tranexamic acid (15 mg/kg body weight, 100 mg/mL tranexamic acid) or the same volume of placebo (0.9% NaCl) was added to a 100-mL saline solution plastic bag. The study medication was given immediately before the start of surgery. Data were analyzed by means of non-parametric statistics and multivariate models adjusted for confounding factors. MAIN OUTCOME MEASURES Blood loss and red blood cell transfusions. RESULTS The total blood loss volume and transfusion rate were significantly lower in the tranexamic acid group compared with the placebo group. Median total blood loss was 520 and 730 mL, respectively (p = 0.03). Fifteen (30%) and 22 (44%), respectively received transfusions (odds ratio 0.44; upper 95% CI 0.97; p = 0.02). CONCLUSION A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates significantly in advanced ovarian cancer surgery. Tranexamic acid may be recommended as standard prophylactic treatment in advanced ovarian cancer surgery. 2014 Nordic Federation of Societies of Obstetrics and Gynecology.
-
10.
A possible association between aprotinin and improved survival after radical surgery for mesothelioma
Norman PH, Thall PF, Purugganan RV, Riedel BJ, Thakar DR, Rice DC, Huynh L, Qiao W, Wen S, Smythe WR
Cancer. 2009;115((4):):833-41.
Abstract
BACKGROUND Aprotinin has been used to decrease blood loss with complicated cardiac surgery but has not been investigated in extrapleural pneumonectomy, an operation that does not use cardiopulmonary bypass. In this prospective, randomized, placebo-controlled, double-blind trial, the authors investigated whether aprotinin decreased blood loss in patients who underwent this operation. METHODS After appropriate statistical design and institutional review board approval, eligible patients who were scheduled for extrapleural pneumonectomy were randomized to receive either aprotinin or placebo during the operation. Blood loss and survival data were obtained from electronic medical records and surgical databases. RESULTS Of 20 patients who were enrolled, 16 patients met criteria for blood loss analysis. Four patients were excluded from the blood loss analysis: Three patients were inoperable because of tumor spread and underwent limited surgery, and 1 patient died intraoperatively because of acute, massive hemorrhage. The mean blood loss was 769 mL with aprotinin versus 1832 mL with placebo (P = . 05; Wilcoxon test). All 20 patients were included in survival analyses. All 9 patients who received placebo died. In contrast, 7 of 11 patients who received aprotinin remained alive at the time of the current report. Kaplan-Meier survival curves differed significantly between the 2 groups (P = . 0004). A Bayesian multivariate survival analysis of 18 patients who had complete data available on 8 prognostic variables indicated a posterior probability of . 99 that aprotinin was beneficial. CONCLUSIONS Aprotinin decreased blood loss. After accounting for covariate effects, there was a significant comparative benefit with aprotinin in postoperative survival. This finding was unexpected and could not be considered conclusive because of the small size of the current study. A confirmatory study may be warranted.